Recent FDA 483 Actions

recent FDA warningAfter discussing the FDA’s ongoing inspections of compounding pharmacies and cGMP, it seems logical to review some of the latest actions that have recently taken place (including new FDA 483 Forms and Warning Letters). Although the FDA has only published recent Warning Letters that were sent by August 31, 2019 (so any issued in September of 2019 or after have not yet been published on the FDA website), two examples from August of this year are perhaps worth taking a more detailed look at. They help to demonstrate how aggressively the FDA is still currently proceeding with their efforts focused directly on these facility inspections.

Office of Unapproved Drugs and Labeling Compliance Warning Letters

Before taking a closer look at the FDA’s most recent actions, it’s important to note that the 483 Forms and Warning Letters were issued by the FDA’s Office of Unapproved Drugs and Labeling Compliance. Other FDA offices that also issue Warning Letters include:
– Office of Prescription Drug Promotion Letters
– Office of Compliance/Immediate Office
– Office of Manufacturing Quality Letters
– Office of Scientific Investigations Letters
– Office of Drug Security, Integrity and Recalls

Please note that we recommend that you should probably take a much closer look at each of the Warning Letter examples used below when time permits. We’ve included a link for each individual Warning Letter from the FDA’s website. In both of the examples, one can see very quickly that the FDA inspectors were quite thorough in their inspection of the facility and their documentation of their observations. In both examples you are able to get a good look at how specific the FDA is in their requirements to address each individual observation, plus how extremely complicated these requirements actually can be. Comprehensive independent reviews by third parties, risk assessments, and detailed plans to alleviate the facility’s issues as quickly as possible are now the norm instead of the exception.

Action #1 –

On 8/19/2019, Haw Par Healthcare Limited received a Warning Letter delivered via UPS from the FDA’s Office of Unapproved Drugs and Labeling Compliance. The warning letter cited numerous significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. The FDA summary basically stated that the facilities’ manufacturing methods and processes did not conform to CGMP. The FDA’s conclusion was that the drug products were therefore considered adulterated as defined in section 501 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Additionally, the FDA stated that a product that Haw Par Healthcare Limited manufactured was misbranded under section 502 of the FD&C Act, and that the “Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a)”.

Click here to view the entire warning letter that Haw Par Healthcare Limited received from the FDA:

Action #2 –

On August 22, 2019 Polimeros y Servicios S.A. also received a warning letter from the FDA’s Office of Unapproved Drugs and Labeling Compliance that essentially was almost identical to the warning letter that Haw Par Healthcare Limited had already received a few days prior.

An actual discussion of each noted observation for each individual warning letter would take several hours, but we strongly recommend that you actually take a very close look at at least one of these warning letters to get an accurate idea of of the the detail  and complexity that’s involved. The warning letter that Haw Par Healthcare Limited received was incredibly almost 2,500 words in total!

Click here to view the entire warning letter that Polimeros y Servicios S.A. received from the FDA:

CGMP Consultant Recommended

In both warning letters, the FDA “strongly” recommended that the facility hire a CGMP consultant. As the Warning Letters actually stated: “Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant, qualified as set forth in 21 CFR 211.34, to assist your firm in meeting CGMP requirements”.

It’s important to note that the FDA is clear that the of a consultant does not relieve the facility or operation of the responsibility to comply with CGMP. It is the firm’s Executive Management that is still ultimately responsible for resolving all of the CGMP violations that exist.

Who Can Help You Prepare For the Inevitable FDA Inspection & Your Response?

Once again, these are just two recent examples of the detailed level of observation and documentation that the FDA inspectors are exhibiting. Keep in mind that the FDA will thoroughly review the facility’s response and revisit to see whether or not the operation is doing their utmost to be in compliance.

Take action now and be prepared! In other words, take a look now and don’t wait for the inevitable inspection that is certain to come! The FDA strongly recommends that you undertake a comprehensive assessment of your facility’s current operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. As the FDA actually states: “A third-party consultant with relevant sterile drug production expertise should assist you in conducting this comprehensive evaluation”. The FDA also points out very clearly that “It is YOUR responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations”.

Which Third-Party Pharmacy Consulting Firm Can Help Me?

Healthcare Consultants has been known as a national leader in pharmacy consulting for over 30+ years now. Since 1989, our network of experienced pharmacy consultants and in-house specialists have provided expert guidance across all sectors of the pharmacy industry. We work with pharmacies of every size – from the corner drug store to national corporations and organizations – with only one goal in mind: to improve your pharmacy’s business operations.

One of the services that HCC specializes in is the development and customization of both 503A and 503B Policies and Procedures. We have nationally renowned in-house experts and consultants with proven “track records” and successful results in responding to both FDA 483 Forms and Warning Letters.

We urge you to contact us today to see how our Pharmacy Consulting services can fit your needs and help you improve your business now, plus be ready for the future. With a full-time staff of experienced in-house Pharmacy Consulting specialists, HCC can answer any questions that you may have in all Pharmacy settings. Contact us online now or call us today at 800-642-1652 for a free consultation.



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