Hetero Labs Limited
FDA inspection history in Hyderabad, India, 2015 to 2023
- 6
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2016: one Form 483; 2018: two Form 483s; 2019: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–19Five Form 483s, at Hyderabad, India.
- 2019The longest 483 on file: 10 observations over 16 pages at Hyderabad, India.
- 2023One Form 483, at Hyderabad, India.
Cited most
Across all Hetero Labs Limited observations on file
- 21 CFR 211.194Laboratory records4
- 21 CFR 211.192Production record review3
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.160General requirements2
- 21 CFR 211.170(b)Reserve samples2
The complete Hetero Labs Limited file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Hyderabad, India
Six Form 483s · 2015 to 2023 · 21 observations
Latest: Form 483, Jul 21, 2023 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-07-21 | 483 Form 483 | Hyderabad, India | 2 | $99 |
| 2019-06-07 | 483 Form 483 | Hyderabad, India | 10 | $99 |
| 2018-10-26 | 483 Form 483 | Hyderabad, India | 2 | $99 |
| 2018-03-23 | 483 Form 483 | Hyderabad, India | 3 | $99 |
| 2016-10-26 | 483 Form 483 | Hyderabad, India | 3 | $99 |
| 2015-07-31 | 483 Form 483 | Hyderabad, India | 1 | $99 |
Investigators on these documents
Rita K. Kabaso (2)Miguel A. Martinez (1)Pratik S. Upadhyay (1)Lucas B. Leake (1)Saundrea A. Munroe (1)Yasamin Ameri (1)Raquel Gonzalez Rivera (1)
FEI number 3005406526 · most recent document Jul 21, 2023
About Hetero Labs Limited
How many FDA Form 483s has Hetero Labs Limited received?
FDA Intel has 6 Form 483s on file for Hetero Labs Limited; the most recent is dated Jul 21, 2023.
When was Hetero Labs Limited last inspected by FDA?
The most recent FDA inspection document on file for Hetero Labs Limited is a Form 483 dated Jul 21, 2023, for the site in Hyderabad, India.
What did FDA cite at Hetero Labs Limited?
The regulations cited most in the observations on file for Hetero Labs Limited are 21 CFR 211.194 (Laboratory records), 4 times; 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.100(a) (Written procedures; deviations), 2 times.