FDA Inspection
Gopers Int LLCGopers Int LLC – FDA Inspection, May 26, 2011
Record Details
This FDA Inspection record concerns Gopers Int LLC, with an inspection on May 26, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Gopers Int LLC
- Inspection Date
- May 26, 2011
- Product Type
- Drugs
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ID · 77fd1882-2a2a-471f-b8ad-1f55174557de
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 726365
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
31- 21 CFR 211.42(c)(10)(i)Floors, walls, ceiling surfaces
- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.94(c)Containers & Closures Clean, Sterilized, Pyrogen-free
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.82(a)Examination on receipt, before acceptance
- 21 CFR 211.84(d)(6)Microbiological Contamination Exam
- 21 CFR 211.25(a)Training , Education , Experience overall
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Other FDA inspections of Gopers Int LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 30, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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