FDA Inspection
East Berlin Pharmacy, Inc. d/b/a Choice HealthcareEast Berlin Pharmacy, Inc. d/b/a Choice Healthcare – FDA Inspection, Jul 6, 2011
Record Details
This FDA Inspection record concerns East Berlin Pharmacy, Inc. d/b/a Choice Healthcare, with an inspection on July 6, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 6, 2011
- Product Type
- Drugs
View Company Profile
ID · 057fcc47-30cb-4ede-af3f-54e919d08215
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 732292
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
- 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 |
|---|---|---|---|
| December 3, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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