Teva API India Private Ltd.
Form 483 issued February 9, 2018 · Gajraula, India
- Inspection
- Feb 5 – Feb 9, 2018
- Investigator
- Kellia N. Hicks
- Observations
- 4
- Pages
- 3
- FEI number
- 3005343793
In short: On February 9, 2018, FDA issued a Form 483 with 4 observations to Teva API India Private Ltd. in Gajraula, Uttar Prades (FEI 3005343793) after an inspection that ran Feb 5 – Feb 9, 2018. The investigator was Kellia N. Hicks. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Facilities & equipment and materials 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
Drug substances are not stored under appropriate conditions of temperature so that their identity, strength, quality…
- 02
Written procedures are lacking for the use of rodenticides, insecticides, fungicides, fumigating agents, cleaning and sanitizing…
- 03
Control procedures are not followed which monitor the output and validate the performance of those manufacturing…
- 04
Equipment used in the manufacture, processing, packing or holding of drug substances is not of appropriate…
This inspection in context
Kellia N. Hicks
28 documents · 2017–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmTeva API India Private Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.142
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Teva API India Private Ltd.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, materials and quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Teva API India Private Ltd.?
Kellia N. Hicks is named on this Form 483, for the inspection of Feb 5 – Feb 9, 2018. Each investigator has a profile showing what they cite most.
When was Teva API India Private Ltd. inspected by FDA?
The inspection ran Feb 5 – Feb 9, 2018, and the Form 483 is dated February 9, 2018.
How do I get the full Form 483 for Teva API India Private Ltd.?
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.