FDA Inspection
Unither Manufacturing LLC.Unither Manufacturing LLC. – FDA Inspection, May 15, 2026
Record Details
This FDA Inspection record concerns Unither Manufacturing LLC., with an inspection on May 15, 2026, issued by the New York District Office, covering human drugs.
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ID · 10236bae-d070-4aa1-a822-0d1720804a61
Inspection Facts
- Inspection number
- 1320018
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.68(b)input/output verification
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Other FDA inspections of Unither Manufacturing LLC.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| December 21, 2018 | VAI | New York District Office | Generic Drug Evaluation |
| March 1, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Unither Manufacturing LLC.
- FDA Inspection 1247547 - 2024-09-06
- FDA Inspection 1155229 - 2021-10-15
- FDA Inspection 1090360 - 2019-05-22
- FDA Inspection 1075470 - 2018-12-21
- FDA Inspection 1003363 - 2017-03-01
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