Do Not Use Infant Head Shaping Pillows to Prevent or Treat Any Medical Condition - FDA.gov

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According to the FDA:

"The U.S. Food and Drug Administration (FDA) recommends that parents and caregivers do not use infant head shaping pillows intended to change an infant’s head shape or symmetry or claim to prevent or treat any medical condition. The FDA is not aware of any demonstrated benefit with the use of infant head shaping pillows for any medical purpose. The use of head shaping pillows can create an unsafe sleep environment for infants and may contribute to the risk of suffocation and death.

Infant head shaping pillows are not FDA-approved. The safety and effectiveness of these products have not been established ... "

Source: 

Do Not Use Infant Head Shaping Pillows to Prevent or Treat Any Medical Condition: FDA Safety Communication - FDA.gov

Do Not Use Baby Neck Floats Due to the Risk of Death or Injury - FDA.gov

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According to the safety communication:

"The U.S. Food and Drug Administration (FDA) is warning parents, caregivers, and health care providers not to use neck floats with babies for water therapy interventions, especially with babies who have developmental delays or special needs, such as spina bifida, spinal muscular atrophy (SMA) type 1, Down syndrome, or cerebral palsy. The use of these products can lead to death or serious injury."

Read the full safety communication:  Do Not Use Baby Neck Floats Due to the Risk of Death or Injury: FDA Safety Communication - FDA.gov

Contact Lens Solutions With Hydrogen Peroxide: To Avoid Injury, Follow All Instructions - FDA

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Read the full article: Consumer Updates > Contact Lens Solutions With Hydrogen Peroxide: To Avoid Injury, Follow All Instructions - FDA:

"Before you use solution with hydrogen peroxide, read all warning labels and instructions. Also note that the tip of the bottle is red. The red coloring is a reminder that these products require special handling.

“You should never put hydrogen peroxide directly into your eyes or on your contact lenses,” Lepri says. That’s because this kind of solution can cause stinging, burning, and damage—specifically to your cornea (the clear surface that covers your eye).

If you use a solution that has hydrogen peroxide you absolutely must follow the disinfecting process with a “neutralizer.” A neutralizer is always sold as part of your hydrogen peroxide cleaning solution kit. It turns the peroxide into water and oxygen, making it safe to put lenses into your eyes."

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FDA Strengthens Warning of Heart Attack and Stroke Risk for Non-Steroidal Anti-Inflammatory Drugs - Consumer Updates

Read the full update: FDA Consumer Updates > FDA Strengthens Warning of Heart Attack and Stroke Risk for Non-Steroidal Anti-Inflammatory Drugs:

"FDA is strengthening an existing warning in prescription drug labels and over-the-counter (OTC) Drug Facts labels to indicate that nonsteroidal anti-inflammatory drugs (NSAIDs) can increase the chance of a heart attack or stroke, either of which can lead to death. Those serious side effects can occur as early as the first few weeks of using an NSAID, and the risk might rise the longer people take NSAIDs. (Although aspirin is also an NSAID, this revised warning doesn’t apply to aspirin.)"

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GMP News: Insufficient failure investigations, supplier qualification, stability testing - the most common GMP violations in the FDA warning letters

Updated August 4, 2024

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Warning Letters - FDA.gov

---  the original post follows below  ---

Read the full article: GMP News: Insufficient failure investigations, supplier qualification, stability testing - the most common GMP violations in the FDA warning letters:

"The analysis of the warning letters issued in the last fiscal year shows no surprise at a first glance: as in recent years the FDA detected an insufficient investigation of unexplained discrepancies and deviations from defined standards and specifications in their inspections. The corresponding paragraph 21 CFR 211.192 

that the drug maker clarifies the reason for the deviation, takes corrective actions and also creates a complete documentation. In the last 5-year period on average annually about 22 companies received a warning letter listing this GMP deficiency. This fact shows that many quality assurance departments' understanding of deviations handling, failure investigations and corrective actions is frequently fragmentary."

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FDA: Foreign medtech firms receive excess manufacturing violations | MassDevice

FDA: Foreign medtech firms receive excess manufacturing violations | MassDevice:

"FDA inspectors have stepped up their surveillance of foreign medical device manufacturers, finding that they make up a disproportionate number of process and quality violations that result in formal warning letters.

Foreign firms accounted for about 10% of inspections conducted in 2012 but received 40% of the FDA warning letters. China alone was responsible for 12% of all the quality systems warning letters issued that year."

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21 CFR 820 Essential Elements - A QSR Training Course

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Do You Have SOP Compliance Problems?

#FDA #GMP #cGMP #QSR #training #course

• Do CGMP documents contain many errors, or
• Are change controls often side-stepped, or 
• Is the Quality Unit often side-stepped, or 
• Are procedures not always followed?

If you answered "Yes" to any of these questions, then take a look at our Qualstar: A CGMP Training Simulation course.

Featured Course:   Qualstar - A CGMP Simulation
Designed to teach and to change the culture of companies in order to focus on quality and compliance. This competitive simulation is an eye-opener for participant and executive staff observers alike. Issues addressed in this exciting simulation:

1. Documentation problems
2. Procedures not being followed
3. Change control not practiced
4. QA not consulted on deviations 

If this describes some of your issues, then you need to experience Qualstar!
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New - FDAzilla's FDA Inspections Database

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Inspection and 483 data sliced and diced in a very interesting way. Check it out! 

Start with the first link below to get oriented, then dive right in to the data via the second link below.

FDA Inspections Database is Now Available | FDAzilla Blog:

"We are proud to unveil the newest edition to the FDAzilla website – the FDA inspection database. You can search for company name, or you can drill down to the month, and then to the day, to see inspection details."

Follow this link to The FDAzilla FDA Inspection Dashboard and Database

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Dietary Supplement Warning Letter Immersion Center - Letters Categorized by Type

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Updated July 22, 2021

The original link broke.

Read more about the topic here:

Warning Letters Related to Food, Beverages, and Dietary Supplements - FDA.gov

---  the original post follows below  ---

If you're tracking FDA Warning Letters issued to dietary supplement companies, follow the link below:

NPI Warning Letter Immersion Center:

"This Warning Letter Immersion Center is a place to find the latest information on warning letters sent to dietary supplement and related companies. Included is a table of all the known warning letters to date, including a link to the full text of each letter on FDA website."

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FDA Says - Use Sunscreen Spray? Avoid Open Flame

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Updated July 28, 2021

The original link broke.

You can still read about this topic here:

FDA reminds consumers spray-on sunscreens can catch fire - CBS News

---  the original post follows below  ---

Consumer Updates > Use Sunscreen Spray? Avoid Open Flame:

"You love a good summer barbecue and wisely use sunscreen if you are out in the sun. What you may not know is that if you apply certain sunscreen sprays and then come close to a source of flame, you may risk the sunscreen catching fire and giving you a serious burn.

The Food and Drug Administration (FDA) has become aware of five separate incidents in which people wearing sunscreen spray near sources of flame suffered significant burns that required medical treatment."

Follow this link to more FDA Sunscreen resources and information

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FDA Cites 70% of Dietary Supplement Firms on GMPs

FDA GMP Inspectors Cite 70% of Dietary Supplement Firms:

"During a three-year period, federal inspectors have cited seven out of 10 facilities that make dietary supplements for violating regulations intended to ensure products are safe and contain the ingredients that are listed on the labels.

A total 444 out of 626 inspections for cGMPs (current Good Manufacturing Practices) resulted in the issuance of a "Form 483," according to data Natural Products INSIDER obtained through a Freedom of Information Act (FOIA) request."

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FDA Warns - DMAA for Wt Loss & Performance Could Be Dangerous

Consumer Updates > Stimulant Potentially Dangerous to Health, FDA Warns:

"The ingredient, DMAA, is most commonly used in supplements promising weight loss, muscle building and performance enhancement; it can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest. Given the known biological activity of DMAA, the ingredient may be particularly dangerous when used with caffeine."

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FDA Seizes Illegal Dietary Supplements in FL

FDA Seizes Illegal Dietary Supplements in FL | Designated Representative and Exemptee:

"WASHINGTON: FDA seizes illegal dietary supplements in Florida - Business Breaking News - MiamiHerald.com:

"Several of the supplements from Globe All Wellness LLC contain the active ingredient in Meridia, a weight loss drug that was withdrawn from the market in 2010. The drug was pulled after studies showed it could increase the risk of heart attack and stroke.

Among other problems, the Hollywood, Florida-based company made unsubstantiated claims about the benefits of its products and did not comply with manufacturing standards."

For additional details:
FDA Warning Letters - Globe All Wellness, LLC 2/6/12

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FDA Warning - GermBullet Is An Unapproved Flu Remedy

FDA warns company over unapproved flu remedy - US News and World Report:

"The Boca Raton, Fla.-based company advertises the product as a "proprietary blend of 11 organic botanicals." The company's website claims that "an FDA recognized virology lab" tested the formula and "confirmed that it has the potential capability to kill cold and flu viruses."

But FDA regulators say the mixture has never been reviewed as safe and effective and the company is violating drug safety regulations. All new drugs marketed in the U.S. must be submitted for approval to the FDA before they can be sold to consumers. The GermBullet is sold online through retailers like CVS.com and at a handful of small pharmacies and natural food stores in Florida."

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FDA - Pharma Warning Letters and Notice of Violation Letters

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Warning Letters and Notice of Violation Letters to Pharmaceutical Companies:

"These letters are supplied by the CDER Freedom of  Information Office (FOI).  This page only covers letters issued by Headquarters and the Office of Prescription Drug Promotion (formerly the Division of Drug Marketing, Advertising, and Communications).  For District Office warning letters, please see the Main FDA FOI Warning Letters Page.

Some of the letters have been redacted or edited to remove confidential information.  Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter. "

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FDA Warning Letters - Common Violations

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Updated April 25, 2024

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Trends In FDA FY2023 Inspection-Based Warning Letters - Outsourced Pharma

---  the original post follows below  ---

The author reports six categories of the most common violations . . .

FDA warning letters: the most common violations highlighted | Life Sciences Articles:

"Before the FDA takes enforcement action on negative inspection findings, it issues a warning letter. From an analysis of 87 such letters, we learned a lot about what the FDA is looking for and ways to keep you from receiving a letter yourself. Here is the countdown of the most common violations mentioned in FDA Warning letters."

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Warning: Your “Check CAPA” Light is On - FDA Form 483

Warning: Your “Check CAPA” Light is On | Ask Cato:

The FDA has reported that over 50% of the top 10 Form FDA 483 observations and warning letters are related to one process: CAPA, otherwise known as Corrective and Preventive Actions.

"The requirements are summarized as follows:

1. Analyze processes to identify the root cause of the nonconformance and to proactively identify potential causes of future nonconformance;
2. Investigate the cause;
3. Identify actions needed to correct and prevent nonconformance recurrence;
4. Validate that the CAPA is effective and does not cause unintended adverse effects;
5. Implement and record changes in procedures to correct and prevent the recurrence of noncompliance;
6. Ensure direct dissemination of CAPA information to those responsible for assuring product quality to ensure adequate training for preventive actions; and
7. Submit the relevant documentation on CAPA for management review."

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FDA Mandates Shocking Cigarette Smoking Images (video)

Beginning September 2012, FDA will require larger, more prominent cigarette health warnings on all cigarette packaging and advertisements in the United States, FDA Cigarette Health Warnings.

They're very much in your face, and on some gut level, pretty shocking, as this video shows:





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Portable Swimming Pools Pose A Danger

Summer started and I'm sweltering.  I work in Pleasanton, CA, and the last two days there have baked as high or near 100 degrees.  ... wishing I had that in-ground or portable swimming pool to cool down.

My mind wanders, as I also have family in New Mexico, and they have an above ground pool with a little one running around.

In the heat of Summer, and in pursuit of watery cool, the danger of portable swimming pool lurks, reports this Pediatrics journal article, Pediatric Submersion Events in Portable - Above-Ground Pools in the United States, 2001–2009.

In a nutshell, the authors conclude that there's a risk:

". . .especially in the under 5-year-old age group. No single strategy will prevent all submersion deaths and injuries; therefore, layers of protection are recommended. Industry is advised to engage in development of protective devices that are effective and affordable for portable pools, including isolation fencing, pool alarms, and safety covers"

Please folks, be thoughtful, wary, and careful this Summer.

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FDA Wants Resource Planning In Corrective Action Plans

According to the The QA Pharm blog,

"The most successful corrective action plans have been those where the direct responsible individuals are named and appear in detailed project plans. There is a clear picture of what success looks like and how to get there. But most of all, the resources are identified to execute the work."

Apparently in an FDA Warning Letter to Teva early this year,  the FDA is telegraphing their desire to see these kinds of elements in a response:

• a plan
• what kind of data will be collected to measure the effectiveness of the plan
• a timeline for the plan
• the identification of resources allocated to address the issue

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