Hetero Labs Limited TSUC Pharma SEZ
FDA inspection history across 2 sites, 2016 to 2022
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2016: one Form 483; 2017: one warning letter; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–17One Form 483 and one warning letter, at Polepally Village, India.
- 2022One Form 483, at Mahabubnagar, India.
- 2022The longest 483 on file: 6 observations over 9 pages at Mahabubnagar, India.
Cited most
Across all Hetero Labs Limited TSUC Pharma SEZ observations on file
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.180General requirements1
- 21 CFR 211.198(b)(2)Complaint files1
- 21 CFR 211.25(a)Personnel qualifications1
- 21 CFR 211.67(b)Equipment cleaning and maintenance1
The complete Hetero Labs Limited TSUC Pharma SEZ file.
All 3 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
Mahabubnagar, India
One Form 483 · 2022 · 6 observations
Latest: Form 483, Aug 12, 2022 →Polepally Village, India
One Form 483 · 2016 · 1 observation
Latest: Form 483, Dec 16, 2016 →
Also: one document not tied to a site.
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-08-12 | 483 Form 483 | Mahabubnagar, India | 6 | $99 |
| 2017-08-15 | Warning letter Warning letter | — | — | $99 |
| 2016-12-16 | 483 Form 483 | Polepally Village, India | 1 | $99 |
Investigators on these documents
Jeffrey P. Raimondi (1)Latorie S. Jones (1)Massoud Motamed (1)
FEI number 3008307735 · most recent document Aug 12, 2022
About Hetero Labs Limited TSUC Pharma SEZ
How many FDA Form 483s has Hetero Labs Limited TSUC Pharma SEZ received?
FDA Intel has 2 Form 483s on file for Hetero Labs Limited TSUC Pharma SEZ; the most recent is dated Aug 12, 2022.
When was Hetero Labs Limited TSUC Pharma SEZ last inspected by FDA?
The most recent FDA inspection document on file for Hetero Labs Limited TSUC Pharma SEZ is a Form 483 dated Aug 12, 2022, for the site in Mahabubnagar, India.
What did FDA cite at Hetero Labs Limited TSUC Pharma SEZ?
The regulations cited most in the observations on file for Hetero Labs Limited TSUC Pharma SEZ are 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.180 (General requirements), 1 time; 21 CFR 211.198(b)(2) (Complaint files), 1 time.
Has Hetero Labs Limited TSUC Pharma SEZ received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Hetero Labs Limited TSUC Pharma SEZ; the most recent is dated Aug 15, 2017.