Incomplete 483 Responses
Copackers & distributors must comply with GMPs
This copacker didn't have most of the basic GMP structure required for handling and distributing dietary supplements, and based on my reading of the letter FDA gave them plenty of opportunity to address their 483 responses. Unfortunately, this company likely didn't seek professional help and has earned a warning letter for poor GMP compliance and insufficient 483 responses.
Here is what we can learn.
Product retentions: We don't often see this cited in warning letters, but it is an integral part of GMPs and product investigations. In my days as a manufacturer, I frequently used product retentions to conduct customer complaints and investigations. I also used these products to help substantiate shelf life expiration dating.
From warning letter. "You must retain reserve samples for one year past the shelf-life date (if shelf-life dating is used), or for two years from the date of distribution of the last batch of dietary supplements."
The reason product retentions are rarely mentioned in warning letters is that they are a pretty simple 483 response. The company needs to update its policies and show its work, meaning it should provide proof that product retentions will be collected and saved for the proper amount of time. This company fell short of proving this to FDA, which is why it was added to the warning letter.
From warning letter. "(from company) [w]e corrected and labeled retention samples before the end of our inspection" and "[w]e have a special location for retention samples and hold for are [sic] required to hold for 2 years for the lot." (from FDA) However, you did not provide any supporting documentation demonstrating you made these corrections. Further, the inspector did not observe any corrections prior to the closeout of the inspection. Consequently, we cannot evaluate the adequacy of your corrections at this time."
Subpart G: This involves receiving dietary supplements for packaging. You will see the company did not prove the corrective action to FDA, which, In this case, should be so simple.
From warning letter. "During the inspection, you did not have any procedures in place for the dietary supplement products you receive for packaging and labeling.
483 response comments from warning letter. "Your "Inbound Policy" failed to provide written procedures regarding the examination of each immediate container or grouping of immediate containers in a shipment of product that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) for appropriate content label, container damage, or broken seals to determine whether the container condition may have resulted in contamination or deterioration of the received product."
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There are several other incomplete 483 responses cited in the letter. Read the full warning letter here.
DATE ORIGINALLY POSTED: 8/14/24
Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.