Teva Women's Health LLC
Form 483 issued March 26, 2025 · Cincinnati, Ohio
- Inspection
- Mar 19 – Mar 26, 2025
- Observations
- 4
- Pages
- 3
- FEI number
- 1526814
In short: On March 26, 2025, FDA issued a Form 483 with 4 observations to Teva Women's Health LLC in Cincinnati, Ohio (FEI 1526814) after an inspection that ran Mar 19 – Mar 26, 2025. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 02
Established laboratory control mechanisms are not followed and documented at…
- 03
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 04
The control systems necessary to prevent contamination…
This inspection in context
Questions about this 483
What did FDA find at Teva Women's Health LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The opening words of each observation are shown on this page.
When was Teva Women's Health LLC inspected by FDA?
The inspection ran Mar 19 – Mar 26, 2025, and the Form 483 is dated March 26, 2025.
How do I get the full Form 483 for Teva Women's Health LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.