Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-06-30.
At a glance
Inspections
7
Form 483s
6
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Jun 2025 – 30 Jun 2025 | Human Drugs | WL | On file |
| 1 Mar 2022 – 25 Mar 2022 | Human Drugs | 483 | View 483 → |
| 6 Oct 2020 – 16 Oct 2020 | Human Drugs | 483 | View 483 → |
| 31 Oct 2018 – 18 Dec 2018 | Human Drugs | WL | View 483 → |
| 27 Feb 2017 – 2 Mar 2017 | Human Drugs | Clean | |
| 24 Apr 2014 – 1 May 2014 | Human Drugs | 483 | View 483 → |
| 8 Dec 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Mar 2022
21 CFR 211.160(a)
Lab controls established, including changes
Cited by Monika Borkowska, Anthony J Donato
25 Mar 2022
21 CFR 211.160(b)(3)
Drug products-sampling procedures/specifications
Cited by Monika Borkowska, Anthony J Donato
25 Mar 2022
21 CFR 211.188(b)(11)
Identification of Persons Performing Significant Steps
Cited by Monika Borkowska, Anthony J Donato
25 Mar 2022
21 CFR 211.188(b)(2)
Identification of Equipment and Lines
Cited by Monika Borkowska, Anthony J Donato
Investigators
FDA investigators tied to this site in the record.
Monika Borkowska2 insp.
Guerlain Ulysse2 insp.
Lata C Mathew1 insp.
Helen Verdel1 insp.
John D Mcintosh1 insp.
Anthony J Donato1 insp.
Robin P Mathew1 insp.
Melissa T Roy1 insp.
Jose M Cayuela1 insp.
Douglas C Kovacs1 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 | 4x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.125(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 211.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(11) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | 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 |
Full site report
Get the verbatim findings behind Unipack LLC'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