Teva API India Private Ltd.
FDA inspection history in Gajraula, India, 2018 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Gajraula, India.
- 2023One Form 483, at Gajraula, India.
- 2023The longest 483 on file: 4 observations over 11 pages at Gajraula, India.
Cited most
Across all Teva API India Private observations on file
- 21 CFR 211.186Master production and control records2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.142Warehousing procedures1
- 21 CFR 211.192Production record review1
- 21 CFR 211.56Sanitation1
The complete Teva API India Private file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Gajraula, India
Two Form 483s · 2018 to 2023 · 8 observations
Latest: Form 483, Jul 18, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-07-18 | 483 Form 483 | Gajraula, India | 4 | $99 |
| 2018-02-09 | 483 Form 483 | Gajraula, India | 4 | $99 |
Investigators on these documents
FEI number 3005343793 · most recent document Jul 18, 2023
About Teva API India Private Ltd.
How many FDA Form 483s has Teva API India Private Ltd. received?
FDA Intel has 2 Form 483s on file for Teva API India Private Ltd.; the most recent is dated Jul 18, 2023.
When was Teva API India Private Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Teva API India Private Ltd. is a Form 483 dated Jul 18, 2023, for the site in Gajraula, India.
What did FDA cite at Teva API India Private Ltd.?
The regulations cited most in the observations on file for Teva API India Private Ltd. are 21 CFR 211.186 (Master production and control records), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.142 (Warehousing procedures), 1 time.