FDA Inspection
Unither Manufacturing LLC.Unither Manufacturing LLC. – FDA Inspection, Dec 21, 2018
Record Details
This FDA Inspection record concerns Unither Manufacturing LLC., with an inspection on December 21, 2018, issued by the New York District Office, covering human drugs.
- Office
- New York District Office
- Person
- Yvesna C. Blaise (Issuing Officer)
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ID · 4da1db72-173d-4db8-85f6-a342098ee63d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1075470
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Unither Manufacturing LLC.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| May 15, 2026 | Not classified | New York District Office | Drug Quality Assurance |
| September 6, 2024 | Not classified | New York District Office | Drug Quality Assurance |
| October 15, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 22, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 1, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Unither Manufacturing LLC.
- FDA Inspection 1320018 - 2026-05-15
- FDA Inspection 1247547 - 2024-09-06
- FDA Inspection 1155229 - 2021-10-15
- FDA Inspection 1090360 - 2019-05-22
- FDA Inspection 1003363 - 2017-03-01
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