FDA Inspection
Safetec Of America, Inc.Safetec Of America, Inc. – FDA Inspection, Nov 25, 2008
Record Details
This FDA Inspection record concerns Safetec Of America, Inc., with an inspection on November 25, 2008, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Safetec Of America, Inc.
- Inspection Date
- November 25, 2008
- Product Type
- Drugs
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ID · a15f6ee6-21fb-4047-a29f-2242515bbbc2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 549816
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.110(a)Written in-process control procedures
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Other FDA inspections of Safetec Of America, Inc.
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|---|---|---|---|
| November 15, 2024 | VAI | New York District Office | Drug Quality Assurance |
| March 6, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 17, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 30, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 8, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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