Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-26.
At a glance
Inspections
6
Form 483s
5
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Sep 2025 – 26 Sep 2025 | Human Drugs | 483 | On file |
| 31 Oct 2022 – 8 Nov 2022 | Human Drugs | 483 | On file |
| 6 May 2019 – 14 May 2019 | Human Drugs | 483 | On file |
| 14 Aug 2017 – 18 Aug 2017 | Human Drugs | 483 | On file |
| 24 Sep 2014 – 29 Sep 2014 | Human Drugs | 483 | On file |
| 15 Dec 2011 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
Tamil Arasu1 insp.
Lisa L Flores1 insp.
Pratik S Upadhyay1 insp.
Lata C Mathew1 insp.
Arsen Karapetyan1 insp.
Rajiv R Srivastava1 insp.
Concepcion Cruz1 insp.
Bijoy Panicker1 insp.
Ivy E Sweeney1 insp.
Daniel J Roberts1 insp.
Sangeeta M Khurana1 insp.
Full site report
Get the verbatim findings behind Hetero Labs Ltd. - Unit IX's 5 Form 483s
The full inspection record, as Atlas holds it, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat