FDA Inspection
Provident Pharmaceuticals LlcProvident Pharmaceuticals Llc – FDA Inspection, Jun 19, 2009
Record Details
This FDA Inspection record concerns Provident Pharmaceuticals Llc, with an inspection on June 19, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 19, 2009
- Product Type
- Drugs
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ID · c66f02a1-8d38-437b-b476-3ca281255c46
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 589032
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.105(b)Distinctive ID or code not recorded in batch record
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.198(b)(1)Written complaint record must include
- 21 CFR 211.110(a)Written in-process control procedures
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Other FDA inspections of Provident Pharmaceuticals Llc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 1, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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