FDA Inspection
Opti Source InternationalOpti Source International – FDA Inspection, Apr 4, 2024
Record Details
This FDA Inspection record concerns Opti Source International, with an inspection on April 4, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e4245de1-c311-4917-9707-1cd623d8be1a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1234985
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.84(e)Rejecting When Specifications Not Met
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.67(b)Written procedures not established/followed
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