FDA Inspection
Stillman Co., Inc.Stillman Co., Inc. – FDA Inspection, Aug 18, 2009
Record Details
This FDA Inspection record concerns Stillman Co., Inc., with an inspection on August 18, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Stillman Co., Inc.
- Inspection Date
- August 18, 2009
- Product Type
- Drugs
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ID · e27e1392-908d-420f-a5f4-02819c46bfff
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 605639
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)(4)Testing in same container - closure system
Showing 10 of 11 citations.
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Other FDA inspections of Stillman Co., Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 20, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 23, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Stillman Co., Inc.
- FDA Inspection 662685 - 2010-05-20
- FDA Inspection 653038 - 2010-03-23
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