FDA Inspection
Pax-All Manufacturing IncPax-All Manufacturing Inc – FDA Inspection, Mar 28, 2014
Record Details
This FDA Inspection record concerns Pax-All Manufacturing Inc, with an inspection on March 28, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Pax-All Manufacturing Inc
- Inspection Date
- March 28, 2014
- Product Type
- Drugs
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ID · 08de2213-b293-412d-b0f6-fd48e4e283af
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 875864
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Pax-All Manufacturing Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 23, 2011 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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