Hetero Drugs Limited
FDA inspection history across 2 sites, 2018 to 2025
- 3
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2020: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–20Two Form 483s, at Mandal, India and Sangareddy district, India.
- 2018The longest 483 on file: 3 observations over 3 pages at Mandal, India.
- 2025One Form 483, at Sangareddy district, India.
Cited most
Across all Hetero Drugs Limited observations on file
- 21 CFR 211.160General requirements1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.25Personnel qualifications1
The complete Hetero Drugs Limited 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
Sangareddy district, India
Two Form 483s · 2020 to 2025 · 3 observations
Latest: Form 483, May 16, 2025 →Mandal, India
One Form 483 · 2018 · 3 observations
Latest: Form 483, Mar 2, 2018 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-05-16 | 483 Form 483 | Sangareddy district, India | 2 | $99 |
| 2020-02-14 | 483 Form 483 | Sangareddy district, India | 1 | $99 |
| 2018-03-02 | 483 Form 483 | Mandal, India | 3 | $99 |
Investigators on these documents
Bryan L. McGuckin (1)Michael Casner (1)Sneha Patel (1)Yvins Dezan (1)
FEI number 3003510514 · most recent document May 16, 2025
About Hetero Drugs Limited
How many FDA Form 483s has Hetero Drugs Limited received?
FDA Intel has 3 Form 483s on file for Hetero Drugs Limited; the most recent is dated May 16, 2025.
When was Hetero Drugs Limited last inspected by FDA?
The most recent FDA inspection document on file for Hetero Drugs Limited is a Form 483 dated May 16, 2025, for the site in Sangareddy district, India.
What did FDA cite at Hetero Drugs Limited?
The regulations cited most in the observations on file for Hetero Drugs Limited are 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.165 (Testing and release for distribution), 1 time; 21 CFR 211.192 (Production record review), 1 time.