FDA Inspection
InvaGen Pharmaceuticals, Inc.InvaGen Pharmaceuticals, Inc. – FDA Inspection, May 25, 2018
Record Details
This FDA Inspection record concerns InvaGen Pharmaceuticals, Inc., with an inspection on May 25, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e3d4a9c8-e980-4a32-9fdf-d26c6a11a868
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1053263
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 314.81(b)(1)(i)Mix-up
- 21 CFR 211.68(b)Backup file not maintained
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)Written program not followed
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Other FDA inspections of InvaGen Pharmaceuticals, Inc.
16| Date | Classification | Office | Project area |
|---|---|---|---|
| February 9, 2026 | Not classified | New York District Office | Generic Drug Evaluation |
| October 25, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 6, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 30, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 20, 2016 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for InvaGen Pharmaceuticals, Inc.
- FDA Inspection 1302076 - 2026-02-09
- FDA Inspection 1223321 - 2023-10-25
- FDA Inspection 1111971 - 2019-12-06
- FDA Inspection 1007073 - 2017-03-30
- FDA Inspection 970802 - 2016-04-20
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