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FDA Inspection
•Teva Womens Health, LLC•February 8, 2019

Teva Womens Health, LLC – FDA Inspection, Feb 8, 2019

Record Details

This FDA Inspection record concerns Teva Womens Health, LLC, with an inspection on February 8, 2019, issued by the Cincinnati District Office, covering human drugs.

Company
Teva Womens Health, LLC
Inspection Date
February 8, 2019
Product Type
Human Drugs
Office
Cincinnati District Office
People
  • James Norman (Issuing Officer)
  • Lauren N. Howard (FDA Associated Person)
View Company Profile

ID · 9e62b96a-2747-43b9-b23a-3f50b0a5a5ad

Inspection Facts

Inspection number
1078871
FDA center
Human Drugs
Project area
Generic Drug Evaluation
Outcome
Form 483 issued

FDA Citations

3
  1. 21 CFR 211.160(b)(3)Acceptance of drug products
  2. 21 CFR 211.165(e)Test methods
  3. 21 CFR 211.165(f)Failing drug products not rejected

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Teva Womens Health, LLC

12
DateClassificationOfficeProject area
March 20, 2026Not classifiedCincinnati District OfficeDrug Quality Assurance
March 26, 2025Not classifiedCincinnati District Office
April 7, 2023NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 8, 2020NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 26, 2018VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 12 other inspections on the company page
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 1038720 - 2018-01-26

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