Teva API India Private Ltd.
Form 483 issued July 18, 2023 · Gajraula, India
- Inspection
- Jul 11 – Jul 18, 2023
- Observations
- 5
- Pages
- 11
- FEI number
- 3005343793
In short: On July 18, 2023, FDA issued a Form 483 with 5 observations to Teva API India Private Ltd. in Gajraula, Uttar Prades (FEI 3005343793) after an inspection that ran Jul 11 – Jul 18, 2023. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.186 (master production and control records).
At a glance
3 of 5 observations on this 483 concern production.
Most cited: 21 CFR 211.186 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You failed to establish control and movement of GMP equipment (labeled new, old, under review to…
- 02
Although your Associate Director of Production and the Operator stated they are obtained…
- 03
In addition, the batch record does not state the amount of in-process sample to be…
- 04
Stopwatch utilized in Room for has no identification number and…
This inspection in context
Questions about this 483
What did FDA find at Teva API India Private Ltd.?
FDA listed 5 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.186 (master production and control records). The opening words of each observation are shown on this page.
When was Teva API India Private Ltd. inspected by FDA?
The inspection ran Jul 11 – Jul 18, 2023, and the Form 483 is dated July 18, 2023.
How do I get the full Form 483 for Teva API India Private Ltd.?
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