FDA Inspection
InvaGen Pharmaceuticals, Inc.InvaGen Pharmaceuticals, Inc. – FDA Inspection, Nov 10, 2010
Record Details
This FDA Inspection record concerns InvaGen Pharmaceuticals, Inc., with an inspection on November 10, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 10, 2010
- Product Type
- Drugs
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ID · 05cd8df7-f8f0-47c9-b2d0-5b2b71bcd313
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 697223
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.115(a)Reprocessing procedures not written or followed
- 21 CFR 211.160(b)(2)In-process samples representative, identified properly
- 21 CFR 211.165(c)Sampling and testing plans not described
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(a)Procedures To Be in Writing
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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 |
| May 25, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 30, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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 1053263 - 2018-05-25
- FDA Inspection 1007073 - 2017-03-30
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