FDA Inspection
ECR Pharmaceuticals Company Inc.ECR Pharmaceuticals Company Inc. – FDA Inspection, Oct 17, 2011
Record Details
This FDA Inspection record concerns ECR Pharmaceuticals Company Inc., with an inspection on October 17, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 17, 2011
- Product Type
- Drugs
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ID · 60d8ef0a-4184-4568-bacb-91f36528e0a4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 749139
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
2- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 314.80(b)Failure to develop written procedures
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