Teva Women's Health LLC
Form 483 issued January 26, 2018 · Cincinnati, Ohio
- Inspection
- Jan 17 – Jan 26, 2018
- Observations
- 4
- Pages
- 4
- FEI number
- 1526814
In short: On January 26, 2018, FDA issued a Form 483 with 4 observations to Teva Women's Health LLC in Cincinnati, Ohio (FEI 1526814) after an inspection that ran Jan 17 – Jan 26, 2018. Most observations concern quality system and laboratory controls.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
- 02
Laboratory records are deficient in that they do not include a complete record of all…
- 03
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained. in…
- 04
Written procedures for the storage of packaging and labeling…
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 quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
When was Teva Women's Health LLC inspected by FDA?
The inspection ran Jan 17 – Jan 26, 2018, and the Form 483 is dated January 26, 2018.
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.