FDA Inspection
Safetec Of America, Inc.Safetec Of America, Inc. – FDA Inspection, Nov 17, 2017
Record Details
This FDA Inspection record concerns Safetec Of America, Inc., with an inspection on November 17, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e0ec6136-43b8-4d5b-bdf3-0ade455c72d6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031525
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.160(b)(3)Sampling/testing of drug products
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
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