GMP Violations & Unanswered 483s Lead to a Warning Letter

Ensure 483 responses are complete

GMP Violations & Unanswered 483s Lead to a Warning Letter

#WarningLetterWednesday involves a company inspected by the FDA last year that received several 483s for common violations like not having proper component and product specifications.


The company submitted 483 responses, but these responses were incomplete which led to a warning letter.


From Warning Letter: “We acknowledge your response, received December 30, 2021, which acknowledged that specific elements needed to be updated and asserted that “[b]y March 31, 2022, MCACO will update and complete component specifications.” However, we are unable to evaluate the adequacy of your corrective action because you did not provide updated finished product specifications for review.”


Here is a Warning Letter Wednesday post about this common GMP violation. 


The lesson here is to ensure that 483 violations are adequately addressed and that all grievances are met. Most 483s can be “walked back” and addressed before they become warning letters. Warning letters should be avoided. Learn more about the ramifications here


Here is a video about the differences between 483s and warning letters. 


Other violations cited in this warning letter include:

* Not verifying a raw material supplier’s Certificate of Analysis (COA). Depending on the supplier’s Certificate of Analysis (COA), without validating the results with a third-party lab landed this company a 483. The FDA requires that manufacturers verify COAs, including microbial and heavy metals.

From Warning Letter: “you have never conducted heavy metal and microbiological tests to confirm results provided by the supplier’s COA.”


* Incomplete Master Manufacturing Records (MMR).

From Warning Letter: “A description of the packaging and a representative label.”

GMPs work backward from the label to ensure there is a 100% label claim at expiration.

From Warning Letter: “Written instructions, including specific actions necessary to perform and verify points, steps or stages in the manufacturing process where control is necessary.”

The MMR is essentially an easily replicated recipe that includes what goes into the blend, how to verify the numbers are correct, and the instructions for mixing and testing.


Here is a very detailed WLW post about GMP violations and best practices. 

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