FDA Inspection
Impax Laboratories, LLC.Impax Laboratories, LLC. – FDA Inspection, Mar 28, 2012
Record Details
This FDA Inspection record concerns Impax Laboratories, LLC., with an inspection on March 28, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Impax Laboratories, LLC.
- Inspection Date
- March 28, 2012
- Product Type
- Drugs
View Company Profile
ID · 9f2f0cf1-bb42-45bc-a341-b8fe6cca6559
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 774547
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.165(c)Sampling and testing plans not followed
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.192No written record of investigation
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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