Overview
- 10 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-07-21.
At a glance
Inspections
10
Form 483s
9
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Jul 2023 – 21 Jul 2023 | Human Drugs | 483 | View 483 → |
| 30 May 2019 – 7 Jun 2019 | Human Drugs | 483 | View 483 → |
| 22 Oct 2018 – 26 Oct 2018 | Human Drugs | 483 | View 483 → |
| 19 Mar 2018 – 23 Mar 2018 | Human Drugs | 483 | View 483 → |
| 17 Oct 2016 – 26 Oct 2016 | Human Drugs | 483 | View 483 → |
| 27 Jul 2015 – 31 Jul 2015 | Human Drugs | 483 | On file |
| 7 Oct 2013 – 11 Oct 2013 | Human Drugs | 483 | View 483 → |
| 15 Dec 2011 | Not recorded | 483 | View 483 → |
| 2 Nov 2009 | Not recorded | 483 | View 483 → |
| 12 Jan 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Jul 2023
21 CFR 211.192
Written record of investigation incomplete
Cited by Saundrea A Munroe, Raquel Gonzalez Rivera
21 Jul 2023
21 CFR 211.194(a)
Complete test data included in records
Cited by Saundrea A Munroe, Raquel Gonzalez Rivera
7 Jun 2019
21 CFR 211.165(a)
Testing and release for distribution
Cited by Rita K Kabaso, Miguel A Martinez
Investigators
FDA investigators tied to this site in the record.
Rita K Kabaso2 insp.
Michael A Charles2 insp.
Saundrea A Munroe1 insp.
Raquel Gonzalez Rivera1 insp.
Miguel A Martinez1 insp.
Yasamin Ameri1 insp.
Pratik S Upadhyay1 insp.
Lucas B Leake1 insp.
Robert C Horan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.186(b)(7) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hetero Labs Limited's 9 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, 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