FDA Inspection
Akorn Operating Company LLCAkorn Operating Company LLC – FDA Inspection, May 19, 2011
Record Details
This FDA Inspection record concerns Akorn Operating Company LLC, with an inspection on May 19, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Akorn Operating Company LLC
- Inspection Date
- May 19, 2011
- Product Type
- Drugs
View Company Profile
ID · fad22736-4d23-4435-8ffe-97e57728a9e9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 725155
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.165(a)Testing and release for distribution
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Akorn Operating Company LLC
10| Date | Classification | Office | Project area |
|---|---|---|---|
| May 17, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 30, 2018 | Not classified | New Jersey District Office | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| May 12, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 4, 2016 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| June 5, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Akorn Operating Company LLC
- FDA Inspection 1169676 - 2022-05-17
- FDA Inspection 1064286 - 2018-08-30
- FDA Inspection 1012024 - 2017-05-12
- FDA Inspection 976869 - 2016-04-04
- FDA Inspection 929221 - 2015-06-05
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.