FDA Inspection
Pax-All Manufacturing IncPax-All Manufacturing Inc – FDA Inspection, Sep 23, 2011
Record Details
This FDA Inspection record concerns Pax-All Manufacturing Inc, with an inspection on September 23, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Pax-All Manufacturing Inc
- Inspection Date
- September 23, 2011
- Product Type
- Drugs
View Company Profile
ID · 7fc1141a-70c3-4399-a394-c50de1119496
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 748921
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.194(e)Stability testing records not included
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.80(a)Written Procedures Not Followed
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Other FDA inspections of Pax-All Manufacturing Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 28, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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