Overview
- 11 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-09-27.
At a glance
Inspections
11
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Sep 2023 – 27 Sep 2023 | Human Drugs | 483 | On file |
| 25 Apr 2019 – 7 May 2019 | Human Drugs | Clean | |
| 18 Sep 2017 – 22 Sep 2017 | Human Drugs | 483 | On file |
| 28 Oct 2014 – 31 Oct 2014 | Human Drugs | 483 | View 483 → |
| 11 Jul 2013 – 26 Jul 2013 | Human Drugs | 483 | View 483 → |
| 24 Jan 2013 | Not recorded | 483 | On file |
| 12 Aug 2011 | Not recorded | 483 | View 483 → |
| 26 Aug 2010 | Not recorded | 483 | On file |
| 28 Dec 2006 | Not recorded | Clean | |
| 16 Jul 2004 | Not recorded | Clean | |
| 16 Jul 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Oct 2014
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by James M Mason, Charanjeet Jassal
31 Oct 2014
21 CFR 211.103
Actual vs. theoretical yields not determined
Cited by James M Mason, Charanjeet Jassal
31 Oct 2014
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by James M Mason, Charanjeet Jassal
31 Oct 2014
21 CFR 211.192
Investigations of discrepancies, failures
Cited by James M Mason, Charanjeet Jassal
Investigators
FDA investigators tied to this site in the record.
James M Mason4 insp.
Amy N Chen1 insp.
David A Oluwo1 insp.
Zhongren Wu1 insp.
Jai P Singh1 insp.
Charanjeet Jassal1 insp.
Jeen S Min1 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 | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | 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 Piramal Critical Care Inc's 7 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