Overview
- 11 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-08-03.
At a glance
Inspections
11
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Jul 2023 – 3 Aug 2023 | Human Drugs | WL | View 483 → |
| 14 Jun 2021 – 18 Jun 2021 | Human Drugs | 483 | View 483 → |
| 11 Jul 2018 – 20 Jul 2018 | Human Drugs | WL | On file |
| 8 Mar 2017 – 24 Mar 2017 | Human Drugs | 483 | View 483 → |
| 4 Feb 2015 – 11 Feb 2015 | Human Drugs | 483 | View 483 → |
| 11 Sep 2012 | Not recorded | Clean | |
| 21 Aug 2009 | Not recorded | 483 | On file |
| 5 Feb 2007 | Not recorded | Clean | |
| 24 Jun 2005 | Not recorded | Clean | |
| 16 Jun 2003 | Not recorded | Clean | |
| 26 Sep 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Aug 2023
21 CFR 211.22(a)
Contract drug products--lack of responsibility
Cited by Jessica S Estriplet, Josh Renzo N Ramilo
3 Aug 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jessica S Estriplet, Josh Renzo N Ramilo
18 Jun 2021
21 CFR 211.100(a)
Absence of Written Procedures
Cited by William J Leonard, Juanita P Versace, Marcia D Fields
18 Jun 2021
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by William J Leonard, Juanita P Versace, Marcia D Fields
18 Jun 2021
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by William J Leonard, Juanita P Versace, Marcia D Fields
Investigators
FDA investigators tied to this site in the record.
Jessica S Estriplet1 insp.
Josh Renzo N Ramilo1 insp.
William J Leonard1 insp.
Juanita P Versace1 insp.
Marcia D Fields1 insp.
Yvesna C Blaise1 insp.
Guerlain Ulysse1 insp.
Nancy F Scheraga1 insp.
Jose M Cayuela1 insp.
Stephen J Mottola1 insp.
Michael R Klapal1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | 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 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
| FDCA 601(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Inopak Ltd's 6 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