Inspect your FDA Inspector Before Your Inspection | FDAZILLA BLOG

Read the full article: Inspect your FDA Inspector Before Your Inspection | FDAZILLA BLOG:

"Each investigator brings their unique perspective, experience and idiosyncrasies, the study of which is demonstrated to be a crucial element of inspection management, readiness, and preparation. With the Inspector Profile, you’ll be able to see the inspector’s:

•  483 issue rate 
• Total inspections 
• Total 483s 
• Most common citations (based on CFR), CFR description, and citation frequency 
• Longest / shortest inspection in duration – all time, last year 
• Total warning letters"

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In-Person Ways to Avoid Form 483 Observations and Warning Letters | MDDI - Free Tips

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Read the full article for free tips: In-Person Ways to Avoid Form 483 Observations and Warning Letters | MDDI Medical Device and Diagnostic Industry News Products and Suppliers:

"For many medical device companies, it's a scary idea that an FDA inspector could show up at your reception desk tomorrow—or even today. Device executives need to ensure that everyone, from their regulatory affairs team to their receptionist, know how to interact with FDA personnel."

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#free #tips

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FDA Shows Up, a Man Runs, and Questions Emerge on China's Drugs - Bloomberg Law

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Read the full article: FDA Shows Up, a Man Runs, and Questions Emerge on China's Drugs - Bloomberg Law:

"When FDA inspectors showed up at a Chinese company that supplies key ingredients to two of the U.S.’s biggest drug companies, a curious thing happened.

After lunch, they walked into a quality control lab on the second floor, where they saw a worker pull what looked like a memory stick from a computer and put it in the pocket of his lab coat. The inspectors asked to see what he’d taken.

And then the man turned and ran."

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Surviving an FDA Inspection - A GMP training course by SkillsPlus Intl Inc.

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Next Time an FDA Inspector Visits, Make Sure Everything is Dusted - Pharmalot - WSJ

Read the full article: Next Time an FDA Inspector Visits, Make Sure Everything is Dusted - Pharmalot - WSJ:

"Records indicated the company supposedly used an oxygen analyzer to obtain test results. But the FDA inspector displayed a Sherlock Holmesian propensity for uncovering discrepancies. The inspector spotted cobwebs running from the portable oxygen analyzer to an adjacent wall, according to the letter. In other words, the analyzer had not been used for, well, a while."

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The Top 15 Medical Device Deficiencies Cited by FDA in 2014 | RAPS

Read the full article, and view graphics: The Top 15 Medical Device Deficiencies Cited by FDA in 2014 | RAPS:

"The US Food and Drug Administration (FDA) has released data on the observations it makes during inspections of medical device facilities, indicating the most common issues faced by medical device companies.

Total 483s Issued Declines for First Time in Six Years"

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View FDA Inspection Data:
FY 2014 Inspectional Observation Summaries - Number of 483s Issued from the System (Inspections ending between 10/1/2013 12:00:00 AM and 9/30/2014 12:00:00 AM)

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Best Practices for Handling FDA Inspections - Pharmaceutical Compliance Monitor

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Updated July 30, 2021

Sadly, the original link broke.

---  the original post follows below  ---

Read the full article: Best Practices for Handling FDA Inspections - Pharmaceutical Compliance Monitor:

"Successfully managing an FDA inspection begins with the development of a clear company policy. It requires frequent employee training so they are in a position to maintain best practices regarding day-to-day procedures. Companies also need to make sure they define the roles and responsibilities of all company employees during an inspection.

Based on 15 years of experience and eight successful FDA inspections, here are some best practices to prepare for a successful FDA Inspection."

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  The FDA conducted 39,774 inspections in 2013 | FDAzilla - FDA INSPECTION READINESS
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  GMP News: Statistical Analysis of FDA's Inspection Findings

GMP News: Statistical Analysis of FDA's Inspection Findings

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Follow this link to view the graph: GMP News: Statistical Analysis of FDA's Inspection Findings:

"The observation summary counts more than 5.000 483 Forms - including in addition to drugs also further fields like foods which have been analysed separately.

Another interesting summary is the webpage with FAQs relating to the 483 Form.

The following graph shows an analysis of the 483 identified during fiscal year 2013." . . .

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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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The FDA conducted 39,774 inspections in 2013 | FDAzilla Blog

The FDA conducted 39,774 inspections in 2013 | FDAzilla Blog:

"The FDA ended 2013 with 39,774 inspections – a 5-year low.  It’s the first time the FDA has conducted less than 40,000 inspections since 2008 (when it conducted 39,522)."

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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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FDA - 70% of Supplement Companies Violate Rules

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FDA official: 70% of supplement companies violate agency rules:

"About 70 percent of the nation's supplement companies have run afoul of the U.S. Food and Drug Administration's manufacturing regulations over the past five years, according to a top agency official.

Consumers are put at risk by poorly measured ingredients, uncleaned manufacturing equipment, pesticides in herbal products, supplements contaminated with illegal prescription medications -- even bacteria in pediatric vitamins, recall notices and agency inspection records have shown."

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8 Key cGMP Areas FDA Inspectors Focus On | FDAzilla Blog

• Respected FDA CGMP online training courses and programs by SkillsPlus Intl Inc.

8 Key cGMP Areas FDA Inspectors Seem to Focus On | FDAzilla Blog:

"As you prepare for your next FDA inspections, bear in mind some of the key focus areas, which were high priorities for FDA inspectors in the last few years—all driven by patient safety concerns, according to a top pharma executive:" . . .

Follow the link above to the list of 8 key areas.

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6 Questions For A Veteran FDA Investigator | FDAzilla Blog

6 Questions For A Veteran FDA Investigator | FDAzilla Blog:

"Today we have the privilege of interviewing former FDA investigator, Luis Chavarria. After 30 years of conducting, managing, and supervising inspections, his insights are worthy of heavy consideration."

You might also be interested in this course:
Surviving an FDA Inspection

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FDA Draft Guidance Summarized: Delaying, Denying, Limiting, or Refusing a Drug Inspection

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Updated November 4, 2020

Some the links broke in the original post below.

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FDA Issues Draft Guidance on Definition of Denying, Delaying, Limiting or Refusing to Permit Inspection - The National Law Review

Guidance for Industry Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection - FDA.gov (PDF)

- - -  original post follows below  - - -

Facility Inspection Guidance Issued by FDA: Delaying, Denying, Limiting, or Refusing a Drug Inspection - FDA Lawyers Blog:

" . . . in particular Section 707 of FDASIA, which added 501(j) to the FD&C Act, the FDA now deems as adulterated a drug that "has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection". (emphasis added)"

Read the draft guidance:
FDA - Draft Guidance for Industry - Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection (PDF)

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What Should I Expect During An Inspection? - FDA Basics

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FDA Basics for Industry > What should I expect during an inspection?:

"FDA may conduct an inspection of your operation for a variety of reasons, such as a routinely scheduled investigation, a survey, or a response to a reported problem. The investigator will present credentials and "Notice of Inspection" (FDA Form 482) upon arriving at your plant. A knowledgeable person in your firm, such as the plant or production manager, preferably designated ahead of time, should accompany the investigator at all times. It is in your best interest to fully understand FDA's inspection procedures. When you are unsure of certain actions taken by the investigator, don't hesitate to ask questions." . . .

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Surviving An FDA Inspection - A live, in-person, onsite, in-plant course

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FDA Inspection - Tips by the FDAzilla Blog

A good quick primer with some useful links to resources . . .

» 20 Resources to Ace Your Next FDA Inspection FDAzilla Blog:

"FDA inspections.  If part of your job includes preparing your cGMP manufacturing facility to be ready at any second for an FDA inspection.  This page is for you.  Here are our top 20 resources and FAQs for you: . . ."

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FDA Warning Letters - Common Violations

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Updated April 25, 2024

The original link broke.

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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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FDA Increases Winery Inspections

FDA Takes a Growing Interest in Winery Safety | News | News & Features | Wine Spectator:

"While winery inspections are not new, they’re being ramped up under the 2011 Food Safety Modernization Act, according to FDA spokeswoman Patricia El-Hinnawy.

The federal law mandates that the FDA inspect all food processing establishments. The frequency of inspections is based on safety risk and compliance history. While wineries are considered low risk because the fermentation process kills pathogens, all food facilities must be inspected within seven years and at least once every five years after that. “The FDA may be conducting more inspections [at wineries] than it has done in the recent past, in order to meet the [law’s] requirements,” El-Hinnawy said."

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FDA Compliance & Enforcement - Inspection of Cosmetics: An Overview

FDA Compliance and Enforcement; Inspection of Cosmetics: An Overview:

"Section 704 of the Federal Food, Drug, and Cosmetic Act (FD and C Act) authorizes FDA to conduct inspections of cosmetic firms at reasonable times, in a reasonable manner, and without prior notice in order to assure compliance with the applicable laws and regulations, to determine whether cosmetics are safe and properly labeled, and to identify possible health risks and other violations of the law.

A number of factors affect how FDA determines that an inspection of a cosmetic establishment may be warranted. These factors may include--but are not limited to--the type of products, the significance of consumer or trade complaints received, the company's compliance history, FDA surveillance and compliance initiatives, and agency resources.

Some things to know about inspections: . . . "

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Follow the link above to read the full FDA article.

Although there are no good manufacturing practice (GMP) regulations for cosmetics, the FDA offers a Good Manufacturing Practice Guidelines (Inspection Checklist). Failure to adhere to GMP may result in an adulterated or misbranded product.

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FDA rethinking food inspections

I wonder what Upton Sinclair would say about the state of current affairs.

FDA rethinking food inspections - DailyHerald.com:

"The surge in imports has also increased the chances of contamination in foods regulated by the FDA. About 80 percent of seafood, 50 percent of fresh fruits and 20 percent of fresh vegetables are imported.

Despite the mounting threats, the FDA and its contractors inspected only 6 percent of the 421,000 domestic and foreign facilities under its watch in 2010, according to the most recent figures. Inspections account for the full-time work of just 1,000 employees. But if a site is linked to an outbreak of illness, inspectors and FDA scientists descend on it, sometimes staying put for weeks.

Under the food-safety bill enacted last year, food companies must adopt plans to spot and prevent hazards. The law also mandates more frequent inspections. For instance, plants that produce or process high-risk foods, including foods connected to previous outbreaks, must be inspected by 2015 and every three years thereafter."

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