Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-08-12.
At a glance
Inspections
6
Form 483s
4
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Aug 2022 – 12 Aug 2022 | Human Drugs | 483 | View 483 → |
| 18 Apr 2019 – 26 Apr 2019 | Human Drugs | 483 | View 483 → |
| 7 Dec 2016 – 16 Dec 2016 | Human Drugs | WL | On file |
| 27 Apr 2015 – 1 May 2015 | Human Drugs | Clean | |
| 13 May 2013 – 24 May 2013 | Human Drugs | 483 | On file |
| 19 Nov 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Aug 2022
21 CFR 211.198(b)(2)
Written record of complaint to include findings, follow-up
Cited by Jeffrey P Raimondi, Guerlain Ulysse
12 Aug 2022
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jeffrey P Raimondi, Guerlain Ulysse
12 Aug 2022
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Jeffrey P Raimondi, Guerlain Ulysse
12 Aug 2022
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Jeffrey P Raimondi, Guerlain Ulysse
12 Aug 2022
21 CFR 211.68(b)
Computer control of master formula records
Cited by Jeffrey P Raimondi, Guerlain Ulysse
Investigators
FDA investigators tied to this site in the record.
Jeffrey P Raimondi1 insp.
Guerlain Ulysse1 insp.
Lata C Mathew1 insp.
Jogy George1 insp.
Massoud Motamed1 insp.
Latorie S Jones1 insp.
Felix Maldonado1 insp.
Steven P Donald1 insp.
Mural B Gavini1 insp.
Farhana Khan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(b)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(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 |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hetero Labs Limited's 4 Form 483s
Source PDFs 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