FDA Inspection
Pharmacreams CorporationPharmacreams Corporation – FDA Inspection, Mar 22, 2011
Record Details
This FDA Inspection record concerns Pharmacreams Corporation, with an inspection on March 22, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Pharmacreams Corporation
- Inspection Date
- March 22, 2011
- Product Type
- Drugs
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ID · 6a725f8d-dba3-470d-8bf4-4c3f6a2c29a5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 713183
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
14- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.84(d)(6)Microbiological Contamination Exam
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
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Other FDA inspections of Pharmacreams Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 5, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 30, 2012 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
Other documents for Pharmacreams Corporation
- FDA Inspection 869833 - 2014-03-05
- FDA Inspection 783813 - 2012-05-30
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