Teva Pharmaceuticals USA, Inc.
Form 483 issued November 10, 2022 · Fairfield, New Jersey
- Inspection
- Nov 1 – Nov 10, 2022
- Observations
- 3
- Pages
- 4
- FEI number
- 2245641
In short: On November 10, 2022, FDA issued a Form 483 with 3 observations to Teva Pharmaceuticals USA, Inc. in Fairfield, New Jersey (FEI 2245641) after an inspection that ran Nov 1 – Nov 10, 2022. Most observations concern facilities & equipment and production.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Deviations from written production and process control procedures are…
This inspection in context
Questions about this 483
What did FDA find at Teva Pharmaceuticals USA, Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. The opening words of each observation are shown on this page.
When was Teva Pharmaceuticals USA, Inc. inspected by FDA?
The inspection ran Nov 1 – Nov 10, 2022, and the Form 483 is dated November 10, 2022.
How do I get the full Form 483 for Teva Pharmaceuticals USA, Inc.?
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.