Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-09-21.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Sep 2023 – 21 Sep 2023 | Human Drugs | 483 | View 483 → |
| 7 Nov 2016 – 15 Nov 2016 | Human Drugs | Clean | |
| 13 May 2013 – 23 May 2013 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Sep 2023
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Jennifer L Huntington, Brandy N Lepage
21 Sep 2023
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Jennifer L Huntington, Brandy N Lepage
21 Sep 2023
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Jennifer L Huntington, Brandy N Lepage
21 Sep 2023
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Jennifer L Huntington, Brandy N Lepage
21 Sep 2023
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Jennifer L Huntington, Brandy N Lepage
Investigators
FDA investigators tied to this site in the record.
Jennifer L Huntington1 insp.
Brandy N Lepage1 insp.
Yasamin Ameri1 insp.
Michael E Maselli1 insp.
Peter E Baker1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.52 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.82(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hetero Labs Limited's 2 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