Every ‘small company’ likes to proclaim it’s uniqueness and the astute one’s do it simply – providing a direct yet compelling message on their website. One such company in the SE USA includes an interview with their SVP, Contract Sales: Human & Animal Health:
[#1] Q: What do you do?
A: We manufacture over-the-counter drug products, cosmetic products, as well as Rx/prescription drug products. Stated simply, we formulate the goop, we buy all the raw materials to mix the goop, we mix the goop, and we fill the goop into whatever packaging the goop is designed to go into……
[#2] Q: How’s your quality?
A: Terrific. We always strive to go above and beyond! We exceed Good Manufacturing Practices (GMP) and have been audited by the FDA as well as the appropriate state agencies. In addition, we are in good standing with every major independent audit firm that is employed by the various retailers that our branded partners sell to. We would welcome the opportunity to give you a tour of our facility so that you could see for yourself…..
[#3] Q: Why should I call you vs. another contract manufacturer?
A: Well… if you’re located in a colder climate, visiting your manufacturer in FL during the cold winter months is a plus, right? … If you’re looking for a contract manufacturer that operates at the fast pace that you operate in, you will not find another contract manufacturer like us. …
Having given you the general picture, here is some “interesting” context, beyond that this manufacturer promises more Northern customers “a hot time in the winter.” A US FDA warning letter was issued from the Texas Division 2 Office for one of their sites, dated 16 APR 2018. When compared with the interview mentioned above, there are some thought provoking contrasts.
During our inspection, our investigators observed specific violations including, but not limited to, the following.
1. Your firm failed to maintain adequate separate defined areas necessary to prevent contamination or mix-up (21 CFR 211.42(c)).
Your firm manufactured topical human drugs [ See #1 above ] and several pesticides in the same building, using shared equipment. [ See #2 above ] It is unacceptable as a matter of CGMP to continue manufacturing drugs using the same equipment that you use to manufacture pesticides or other non-pharmaceutical products due to the risk of cross-contamination.
Records we reviewed during our inspection and information you submitted in your response confirmed that two of the human drugs you manufactured contained the pesticide (b)(4). You manufactured the pesticide and the human drugs using shared equipment.
In your response, you committed to improving your contamination controls [ See #3 above ] and to test for the presence of other cross-contaminating pesticides in other human drugs that you manufacture.
For those not familiar with the ‘ (b)(4) ‘ as seen above, that is the standard method for identifying information redacted as proprietary under FOIA (Freedom Of Information Act. This brief excerpt may encourage you to read the full warning letter. If that is the case you may find it by following this link (or using the reference code on fda.gov ) – ucm606805 . If you are interested in fully exploring the excerpted interview, please click here.
As a small or medium size company, regulatory inspection or interference/ censure is not something you probably appreciate. In some cases, it would seem to be “warranted.” Since this is not an ex-US (outside of the United States) company, the Food & Drug Administration has no ability to bar product from this site (they actually have 2 – “Both sites are virtual mirrors of each other “). For that reason, an import alert cannot apply. These words from the warning letter “Conclusion” section do:
“Correct the violations cited in this letter promptly. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction.” EOD