FDA Inspection
P & J Oxyfill, LLCP & J Oxyfill, LLC – FDA Inspection, Feb 17, 2010
Record Details
This FDA Inspection record concerns P & J Oxyfill, LLC, with an inspection on February 17, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- P & J Oxyfill, LLC
- Inspection Date
- February 17, 2010
- Product Type
- Drugs
View Company Profile
ID · 44a86540-f88a-46be-a077-efcc006f174c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 648301
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of P & J Oxyfill, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 13, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for P & J Oxyfill, LLC
- FDA Inspection 822236 - 2013-03-13
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