FDA Inspection
Auxigen Pharmaceutical, LLCAuxigen Pharmaceutical, LLC – FDA Inspection, Jul 8, 2014
Record Details
This FDA Inspection record concerns Auxigen Pharmaceutical, LLC, with an inspection on July 8, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Auxigen Pharmaceutical, LLC
- Inspection Date
- July 8, 2014
- Product Type
- Drugs
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ID · d9c17275-7152-4a48-8ac3-ed4283fb785c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 887645
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)(1)Incoming lots - conformance to written specs-
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.84(b)Representative Samples
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Other FDA inspections of Auxigen Pharmaceutical, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 14, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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