FDA Inspection
Teva Womens Health, LLCTeva Womens Health, LLC – FDA Inspection, Nov 10, 2016
Record Details
This FDA Inspection record concerns Teva Womens Health, LLC, with an inspection on November 10, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Christina L. Bigham (FDA Associated Person)
- Teresa K. Kastner
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ID · 92aeec4d-63ac-439b-8f14-f746ca38633b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 991799
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Teva Womens Health, LLC
12| Date | Classification | Office | Project area |
|---|---|---|---|
| March 20, 2026 | Not classified | Cincinnati District Office | Drug Quality Assurance |
| March 26, 2025 | Not classified | Cincinnati District Office | |
| April 7, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 8, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 8, 2019 | Not classified | Cincinnati District Office | Generic Drug Evaluation |
Other documents for Teva Womens Health, LLC
- FDA Inspection 1308790 - 2026-03-20
- FDA Inspection 1265070 - 2025-03-26
- FDA Inspection 1205874 - 2023-04-07
- FDA Inspection 1116385 - 2020-01-08
- FDA Inspection 1078871 - 2019-02-08
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