FDA Inspection
Impax Laboratories, LLC.Impax Laboratories, LLC. – FDA Inspection, Jan 21, 2011
Record Details
This FDA Inspection record concerns Impax Laboratories, LLC., with an inspection on January 21, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Impax Laboratories, LLC.
- Inspection Date
- January 21, 2011
- Product Type
- Drugs
View Company Profile
ID · 7c22d0c0-7ae1-40c6-93f6-02d14312710d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 702914
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.188(a)Accurate reproduction included
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.65(b)Substances That Come in Contact
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Impax Laboratories, LLC.
14| Date | Classification | Office | Project area |
|---|---|---|---|
| January 18, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 23, 2017 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| November 18, 2016 | Not classified | San Francisco District Office | |
| May 4, 2016 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 8, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Impax Laboratories, LLC.
- FDA Inspection 1080691 - 2019-01-18
- FDA Inspection 1023293 - 2017-08-23
- FDA Inspection 1045691 - 2016-11-18
- FDA Inspection 974379 - 2016-05-04
- FDA Inspection 929678 - 2015-05-08
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