FDA Inspection
Amneal Pharmaceuticals of New York, LLCAmneal Pharmaceuticals of New York, LLC – FDA Inspection, Mar 18, 2019
Record Details
This FDA Inspection record concerns Amneal Pharmaceuticals of New York, LLC, with an inspection on March 18, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 5abdbe35-fbda-4f7f-b021-af16d83d00e0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1082937
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.142(b)Storage under appropriate conditions
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Amneal Pharmaceuticals of New York, LLC
10| Date | Classification | Office | Project area |
|---|---|---|---|
| February 3, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 11, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 9, 2016 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| March 16, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 7, 2014 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Amneal Pharmaceuticals of New York, LLC
- FDA Inspection 1118990 - 2020-02-03
- FDA Inspection 1007417 - 2017-04-11
- FDA Inspection 982074 - 2016-08-09
- FDA Inspection 918318 - 2015-03-16
- FDA Inspection 865012 - 2014-02-07
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.