FDA Inspection
Safetec Of America, Inc.Safetec Of America, Inc. – FDA Inspection, Nov 15, 2024
Record Details
This FDA Inspection record concerns Safetec Of America, Inc., with an inspection on November 15, 2024, issued by the New York District Office, covering human drugs.
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ID · 0b547073-dbfd-4aea-8de4-5ed5300323db
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1254211
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.160(b)Scientifically sound laboratory controls
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Other FDA inspections of Safetec Of America, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| June 21, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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