FDA Inspection
East Berlin Pharmacy, Inc. d/b/a Choice HealthcareEast Berlin Pharmacy, Inc. d/b/a Choice Healthcare – FDA Inspection, Dec 3, 2012
Record Details
This FDA Inspection record concerns East Berlin Pharmacy, Inc. d/b/a Choice Healthcare, with an inspection on December 3, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 3, 2012
- Product Type
- Drugs
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ID · c8c785f3-591e-4fb9-bbd6-ac4198a8c68b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 810502
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.198(a)Quality Control Review
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of East Berlin Pharmacy, Inc. d/b/a Choice Healthcare
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 6, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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