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What would elicit this type of response from FDA?
More than 67,000 Power Stick deodorants made by A.P. Deauville recalled
A classic case of curiosity killed the cat…….. What would cause the FDA to initiate this type of response. The wording is of course….beyond vague.
1) Could this happen….with just observation of unsanitary process/methods/storage/cleaning etc?
2) Or would there need to be some microbial evidence to generate this?
I guess I am asking….if they simply operated in gross conditions…is that enough….or would there need to be some microbial contamination to escalate to this level?
Aloha
cosmeticsbusiness.com
More than 67,000 Power Stick deodorants made by A.P. Deauville recalled
The US Food and Drug Administration (FDA) has recalled cases of deodorant due to deviations from manufacturing regulations
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2 Replies
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These are drug products (antiperspirants) so FDA has more power of recall than for cosmetics. I’ll look for FDA’s documentation and get back to you.
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This reply was modified 4 hours, 50 minutes ago by PhilGeis.
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This reply was modified 4 hours, 50 minutes ago by
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483 from last January. You can see a little of the relevant 483. Looks like real poor GMP’s - not even documenting making. Bet they were dinged for not following making SOP’s. Bet they blew off the agency.
https://www.fda483s.com/fdadocs/a-p-deauville-llc-easton-united-states-of-america-5/
They’re talking the AP product https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=927db52f-90c8-4f4b-a61d-b84cc5a38fe7
Deauville has been in trouble before https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ap-deauville-llc-586306-11082019
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