FDA Inspection
Akorn Operating Company LLCAkorn Operating Company LLC – FDA Inspection, Aug 30, 2018
Record Details
This FDA Inspection record concerns Akorn Operating Company LLC, with an inspection on August 30, 2018, issued by the New Jersey District Office, covering animal drugs & feeds.
- People
- Atul Agrawal (Issuing Officer)
- Guerlain Ulysse (FDA Associated Person)
- Ko U. Min (FDA Associated Person)
- Tamil Arasu (FDA Associated Person)
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ID · df13637c-d93c-47a6-8ff6-82a8b2fb4b3c
Inspection Facts
- Inspection number
- 1064286
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(3)Drug product sample
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)(8)Identification of Person Performing Review of Lab Records
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
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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 |
| 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 |
| May 29, 2014 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Akorn Operating Company LLC
- FDA Inspection 1169676 - 2022-05-17
- FDA Inspection 1012024 - 2017-05-12
- FDA Inspection 976869 - 2016-04-04
- FDA Inspection 929221 - 2015-06-05
- FDA Inspection 884894 - 2014-05-29
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