FDA Inspection
Oxarc, LLCOxarc, LLC – FDA Inspection, Jan 11, 2018
Record Details
This FDA Inspection record concerns Oxarc, LLC, with an inspection on January 11, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 79458e5f-a68d-41ba-86a0-978f488844e8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1037888
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(a)Approval and review of procedures
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