FDA Inspection
Wayne County Chapter of NYARCWayne County Chapter of NYARC – FDA Inspection, Sep 16, 2020
Record Details
This FDA Inspection record concerns Wayne County Chapter of NYARC, with an inspection on September 16, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 16, 2020
- Product Type
- Drugs
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ID · 94ac629e-6be8-4451-bf43-f726f82559d2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1129358
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.184(d)Labeling: documentation of exam and review
- 21 CFR 211.22(a)Lack of quality control unit
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