FDA Inspection
ProCore Pharma, LLCProCore Pharma, LLC – FDA Inspection, May 4, 2009
Record Details
This FDA Inspection record concerns ProCore Pharma, LLC, with an inspection on May 4, 2009, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- ProCore Pharma, LLC
- Inspection Date
- May 4, 2009
- Product Type
- Food/cosmetics
View Company Profile
ID · b1d27e58-3ffb-4e53-a525-4b4bff5c9285
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 582249
- FDA center
- Foods & Cosmetics
- Project area
- Colors and Cosmetics Technology
FDA Citations
7- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.82(b)Quarantine Storage of Components
- 21 CFR 211.115(a)Reprocessing procedures not written or followed
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.67(b)Written procedures not established/followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ProCore Pharma, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 26, 2013 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| September 8, 2011 | OAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for ProCore Pharma, LLC
- FDA Inspection 844207 - 2013-06-26
- FDA Inspection 742077 - 2011-09-08
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