California Exemptee Certification - SkillsPlus International Inc.

• Approved training program for California HMDR Exemptee license applicants and their supervisors/managers - offered by SkillsPlus International Inc.

SkillsPlus International Inc. HMDR Exemptee Training

California requires home medical device retailers (HMDR) & durable medical equipment (DME) providers to retain an on-site Exemptee (who must be physically present during all hours of operation) to conduct their business. 

California Exemptee Certification

This course is approved & recommended by the California Department of Public Health (CDPH), as it meets their training certification requirements. 

If you are applying for a California HMDR Exemptee license, then you'll need to include proof of required training in your license application (a course completion certificate, or a transcript).

SkillsPlus International Inc. offers a state-approved training course for HMDR Exemptee license applicants. Successful course completion earns a course completion certificate (accepted by the California Department of Public Health - Food and Drug Branch), that serves as proof of required training. Include the course completion certificate in your license application submission.

• Learn more, buy now! California Exemptee Training Certification Program.
• $525 per student. 
• no extra fees to retake quizzes.  
• online training certification
• available 24 x 7 - come and go as you like
• covers required topics specified in the California HMDR Exemptee license application. Each topic has a topic exam.
• earns a course completion certificate accepted by the CDPH. 
• nearly 10,000 students have taken our state license-related training courses

Approved training program for California HMDR Exemptee license applicants and their supervisors/managers - offered by SkillsPlus International Inc.

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FDA warns company marketing unapproved cannabidiol products - FDA.gov

• FDA cGMP QSR GMP Online Training Courses by SkillsPlus International Inc.

Read the full news release:  FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety  -  Agency is expediting work to evaluate regulatory policies related to cannabis and cannabis-derived ingredients like CBD - FDA.gov

According to the news release:

"... the U.S. Food and Drug Administration announced that it has issued a warning letter to Curaleaf Inc., of Wakefield, Massachusetts, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases.  ... 

The FDA has previously sent warning letters to other companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the Federal Food, Drug and Cosmetic Act because they were marketed as dietary supplements or because they involved the addition of CBD to food."

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Exemptee Certification Class
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Inspection Observations - FDA.gov

Go to this FDA webpage:  Inspections > Inspection Observations - FDA.gov:

"FDA’s Office of Regulatory Affairs (ORA) is the lead office for all field activities, including inspections and enforcement. During an inspection, ORA investigators may observe conditions they deem to be objectionable. These observations, are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements.

Spreadsheets summarizing the areas of regulation cited on FDA's system-generated 483s are available by fiscal year on the menu links on this page. These spreadsheets are not a comprehensive listing of all inspectional observations but represent the area of regulation and the number of times it was cited as an observation on an FDA Form 483 during inspections conducted by FDA and its representatives. Turbo EIR is FDA's automated Form 483 reporting system. Turbo EIR is utilized to generate the FDA Form 483 when applicable cite modules exist. Not all FDA Form 483s are generated in TurboEIR as some 483s are manually prepared and not available in this format. Observations have been broken out by Product or Program Area on separate tabs of the spreadsheet. The Product and Program Areas include the following:

• Biologics
• Drugs
• Devices
• Human Tissue for Transplantation
• Radiological Health
• Parts 1240 and 1250"

'via Blog this'

In fiscal year 2014, you'll notice that biologics and drugs areas were highly associated with some kind of sub-standard investigation.

You might also be interested in this workshop:

Root Cause Analysis for Better Investigations - a cGMP Training Workshop by SkillsPlus Intl Inc.

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The Only Vote That Counts: FDA 483 Round-Up

The Only Vote That Counts: FDA 483 Round-Up:

"Looking at the FDA isn’t much different. Lots of folks like to predict what the FDA will do, or try to glean trends from the often cryptic public statements FDA officials make at conferences or other gatherings.  But the FDAs real “votes” are in the 483s they issue.

Reading through a recently-released crop of the agency’s medical device letters, it looks like the FDA is maintaing an interest in CAPA and employee training."

'via Blog this'

You might also be interested in:
Root Cause Analysis for Better Investigations - Live On-Site Training Course

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Related articles

• FDA's Top Supplement Issues (drughealth.blogspot.com)

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."

'via Blog this'

You might also be interested in:
Root Cause Analysis for Better Investigations - A highly recommended QSR or GMP training course

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Related articles

• FDA Form 483 Can Form Basis of Class Action Lawsuit (drughealth.blogspot.com)

FDA Inspection Classification Database Search - Free

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FDA Inspection Classification Database Search:   'via Blog this'

Wow! The FDA is disclosing inspection information to help improve the public’s understanding of how the FDA works to protect the public health. Disclosure of the compliance status of firms helps to provide the public with a rationale for the Agency’s enforcement actions and will also help to inform public and industry decision-making, allowing them to make more informed marketplace choices and help to encourage compliance.

In this inspections database, the FDA is specifically disclosing the final inspection classification for inspections conducted of clinical trial investigators, Institutional Review Boards (IRB), and facilities that manufacture, process, pack, or hold an FDA-regulated product that is currently marketed.

Have a go at it!

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Seven Strategies for Avoiding a 483

Updated January 18, 2017

The link in the original post broke.

You might also be interested in:
In-Person Ways to Avoid Form 483 Observations and Warning Letters - MDDI

- -  original post follows below  - -

Seven Strategies for Avoiding a 483:  'via Blog this'

"What a 483 is — and isn’t. After inspecting a food, drug, medical device, or biologic establishment, FDA prepares a written report of its inspection findings, following a debriefing. This report is intended primarily for internal FDA use and is not provided to the inspected institution at the conclusion of the on-site visit."

A nice, quick and easy primer on 483s.

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• PDA FDA - Interesting Manufacturer Statistics (skillsplusinfo.blogspot.com)

Surviving FDA Enforcement Actions - Free Tips

Life in FDA’s fast lane | News | Packaging World:  'via Blog this'

In the article, LeeAnn Rogus offers many tips. Here's just one of the many pearls of wisdom that's shared:

"The 15 days FDA gives a company to respond to a Form 483 inspectional observation has always existed, but the agency would usually let you have extra time. Not any more."

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Will the FDA issue 10,000+ 483s in 2011?

FDA will issue 10,000+ 483s in 2011 – one every 52 minutes FDAzilla Blog:   'via Blog this'

The number is kind of shocking!  According to the FDAzilla Blog:

"Based on new data obtained by FDAzilla, the FDA should surpass 10,000 483s in 2011 for the second time in its history, breaking its all-time record for the third consecutive year."

According to e-How - The Definition of FDA 483:

FDA Form 483, is the form on which inspectors for the Food and Drug Administration detail unsatisfactory results of their inspection of manufacturing facilities for compliance with current good manufacturing practices (cGMP). The FDA inspects plants making human drugs (both prescription and over-the-counter drugs), animal and veterinary drugs, medical devices, food, radiation-emitting products, vaccines, blood and biological products and cosmetics for compliance with cGMP.

You might also be interested in:

Inspection Detection - a GMP training game by SkillsPlus Intl Inc.

An extensive library of 483 citation summaries from the FDA. Match the case with the corresponding 21 CFR 211 reference. Used as a classroom training tool or for self-study, this training aid challenges the student to identify and justify the 21 CFR 211 reference that supports the 483 citation.

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FDA Form 483 Search Tool

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Updated January 27, 2021

Links in the original post broke.

FDAzilla is now a part of Redica Systems (formerly Govzilla)

You might also be interested in:

 Inspection Observations - FDA.gov

- - -  original post follows below  - - -

FDAzilla offers a specialized search tool that makes it possible to search for Form 483 observations issued by the FDA.

One possible use of the search tool is to get a listing of Form 483s issued to companies in a particular country, for example, the search results of form 483 observations issued to companies in India.  Just alter your search keywords to view different results.

Related reading:  Compliance Remediation for Pharmaceutical Manufacturing: A Project Management Guide for Re-establishing FDA Compliance

You might also be interested in:

Inspection Detection - a GMP training game by SkillsPlus Intl Inc.

An extensive library of 483 citation summaries from the FDA. Match the case with the corresponding 21 CFR 211 reference. Used as a classroom training tool or for self-study, this training aid challenges the student to identify and justify the 21 CFR 211 reference that supports the 483 citation.

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FDA - 8 Free Tips For Effective 483 Responses

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Updated February 2, 2021

The original link broke.

People also ask about:

FDA Form 483 Frequently Asked Questions - FDA.gov

- - -  original post follows below  - - -

OK, now that you've gotten that darn 483, now what?!

Here are 8 free tips on how to effectively respond to a 483 (pdf), and these tips come from the FDA.

FDA Guidance - Device Registration and Listing Requirements

• FDA cGMP QSR GMP Online Training - popular cGMP online training classes offered by SkillsPlus International Inc.

Updated January 27, 2021

The links in the original post broke.

You might also be interested in:

Device Registration and Listing - FDA.gov

- - -  original post follows below  - - -

The Food and Drug Administration (FDA) announced the availability of the guidance entitled "Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007.'' The purpose of this guidance is to explain recent changes in the device registration and listing program to owner/operators and official correspondents of device establishments and to help them fulfill these new requirements. The guidance also describes the information that owner/operators of device establishments must submit to register their establishments and list their devices electronically, using FDA Form No. 3673. Those owner/operators seeking a waiver from the electronic submission requirement must submit their requests in writing to FDA with a complete explanation of why their registration and listing information cannot reasonably be submitted electronically. This guidance document is immediately in effect, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs). 

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FDA Says You Only Have 15 Days To Respond To Form 483

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Updated September 7, 2021

The links broke in the original post.

You can still read about the topic here:

The Emergency Guide To FDA Warning Letters & FDA 483. How to handle inspectional observations and warning letters from the FDA. A White Paper by The FDA Group LLC.

---  the original post follows below  ---

According to this PharmTech article, FDA Begins Enforcing Deadlines on Form 483 Responses, you have only 15 days to respond to a form 483. Be aware, this article states:

Now, however, FDA “will not ordinarily delay the issuance of a warning letter in order to review a response to an FDA 483 that is received more than 15 business days after the FDA 483 was issued,” according to an announcement in the Federal Register.

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FDA Says - Unwise To Ignore Form 483

I've taken for granted that no one would intentionally want to ignore an FDA Form 483. But just in case you thought about it, you'll want to reconsider. Read this Outsourcing-Pharma post, "Ignore a form 483? Not wise say FDA." Bottomline, doing nothing increases the likelihood of receiving a warning letter. In summary the FDA believes that “a well-reasoned, complete, and timely 483 response is in your best interest”. 

Related Posts: Medical Device Sponsors - FDA Trends and Tips To Avoid 483s More FDA 483 Resources - Comments and Pearls from Validation Online FDA 483 Inspectional Observations - learn from these examples 

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