FDA Inspection
Safetec Of America, Inc.Safetec Of America, Inc. – FDA Inspection, May 27, 2010
Record Details
This FDA Inspection record concerns Safetec Of America, Inc., with an inspection on May 27, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Safetec Of America, Inc.
- Inspection Date
- May 27, 2010
- Product Type
- Drugs
View Company Profile
ID · f3f1e086-1046-49ce-bf2e-d9993c7c75d9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 669151
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
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| November 15, 2024 | VAI | New York District Office | Drug Quality Assurance |
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| October 30, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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