Hetero Labs Limited, Unit-EX
FDA inspection history across 2 sites, 2019 to 2025
- 3
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2022: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Anakapalli, India.
- 2022One Form 483, at Anakapalli, India.
- 2025One Form 483, at Narasapmam Village, India.
- 2025The longest 483 on file: 6 observations over 14 pages at Narasapmam Village, India.
Cited most
Across all Hetero Labs Limited, Unit-EX observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.125Labeling issuance1
- 21 CFR 211.142Warehousing procedures1
The complete Hetero Labs Limited, Unit-EX 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
Anakapalli, India
Two Form 483s · 2019 to 2022 · 9 observations
Latest: Form 483, Nov 8, 2022 →Narasapmam Village, India
One Form 483 · 2025 · 6 observations
Latest: Form 483, Sep 26, 2025 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-09-26 | 483 Form 483 | Narasapmam Village, India | 6 | $99 |
| 2022-11-08 | 483 Form 483 | Anakapalli, India | 6 | $99 |
| 2019-05-14 | 483 Form 483 | Anakapalli, India | 3 | $99 |
Investigators on these documents
Arsen Karapetyan (1)Lisa L. Flores (1)Pratik S. Upadhyay (1)Rajiv R. Srivastava (1)Tamil Arasu (1)
FEI number 3009093782 · most recent document Sep 26, 2025
About Hetero Labs Limited, Unit-EX
How many FDA Form 483s has Hetero Labs Limited, Unit-EX received?
FDA Intel has 3 Form 483s on file for Hetero Labs Limited, Unit-EX; the most recent is dated Sep 26, 2025.
When was Hetero Labs Limited, Unit-EX last inspected by FDA?
The most recent FDA inspection document on file for Hetero Labs Limited, Unit-EX is a Form 483 dated Sep 26, 2025, for the site in Narasapmam Village, India.
What did FDA cite at Hetero Labs Limited, Unit-EX?
The regulations cited most in the observations on file for Hetero Labs Limited, Unit-EX are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.22 (Responsibilities of quality control unit), 3 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times.