FDA Inspection
ProCore Pharma, LLCProCore Pharma, LLC – FDA Inspection, Sep 8, 2011
Record Details
This FDA Inspection record concerns ProCore Pharma, LLC, with an inspection on September 8, 2011, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- ProCore Pharma, LLC
- Inspection Date
- September 8, 2011
- Product Type
- Veterinary
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ID · c72ac474-df0d-4035-a7d6-c0e2cbfbeb54
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 742077
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
13- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 111.12(c)Personnel - education, training, experience
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.160(a)Lab controls established, including changes
- 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
- 21 CFR 111.155(c)(1)Components - representative samples
- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
Showing 10 of 13 citations.
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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 |
| May 4, 2009 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
Other documents for ProCore Pharma, LLC
- FDA Inspection 844207 - 2013-06-26
- FDA Inspection 582249 - 2009-05-04
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