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FDA Inspection
•Oxarc Inc•May 20, 2011

Oxarc Inc – FDA Inspection, May 20, 2011

Record Details

This FDA Inspection record concerns Oxarc Inc, with an inspection on May 20, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Oxarc Inc
Inspection Date
May 20, 2011
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 8d95e052-e5a7-4e0b-ab99-6af67e5a2143

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
725283
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

4
  1. 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
  2. 21 CFR 211.25(a)GMP Training Frequency
  3. 21 CFR 211.142Written warehousing procedures established/followed
  4. 21 CFR 211.22(d)Procedures not in writing, fully followed

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