FDA Inspection
InvaGen Pharmaceuticals, Inc.InvaGen Pharmaceuticals, Inc. – FDA Inspection, May 12, 2009
Record Details
This FDA Inspection record concerns InvaGen Pharmaceuticals, Inc., with an inspection on May 12, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 12, 2009
- Product Type
- Drugs
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ID · 8426df4d-60b7-4c03-8712-11bcc72e97c9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 579549
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 314.80(f)(1)Wrong form - domestic ADE
- 21 CFR 314.80(c)(2)(ii)(A)Incomplete periodic safety report
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 314.80(c)(1)(iii)Non-applicant reports directly to FDA
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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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