Overview
- 22 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-28.
At a glance
Inspections
22
Form 483s
6
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Aug 2025 – 28 Aug 2025 | Human Drugs | Clean | |
| 5 Sep 2024 – 12 Sep 2024 | Human Drugs | Clean | |
| 24 Aug 2021 – 31 Aug 2021 | Human Drugs | Clean | |
| 9 Dec 2019 – 13 Dec 2019 | Human Drugs | Clean | |
| 26 Mar 2019 – 29 Mar 2019 | Human Drugs | Clean | |
| 12 Oct 2017 – 13 Oct 2017 | Human Drugs | Clean | |
| 8 Aug 2016 – 11 Aug 2016 | Human Drugs | Clean | |
| 19 Feb 2015 – 24 Feb 2015 | Human Drugs | Clean | |
| 5 Aug 2014 – 12 Aug 2014 | Human Drugs | Clean | |
| 10 Feb 2014 – 21 Feb 2014 | Human Drugs | Clean | |
| 11 Sep 2013 – 13 Sep 2013 | Human Drugs | Clean | |
| 7 Mar 2013 – 26 Mar 2013 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Jun 2012
21 CFR 211.22(a)
Contract drug products--lack of responsibility
Cited by Justine Tomasso, Erin D Mccaffery
11 Jun 2012
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Justine Tomasso, Erin D Mccaffery
11 Jun 2012
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Justine Tomasso, Erin D Mccaffery
11 Jun 2012
21 CFR 211.68(b)
Backup data not assured as exact and complete
Cited by Justine Tomasso, Erin D Mccaffery
11 Jun 2012
21 CFR 211.68(b)
Computer control of master formula records
Cited by Justine Tomasso, Erin D Mccaffery
Investigators
FDA investigators tied to this site in the record.
Paul L Bellamy4 insp.
Justine Tomasso3 insp.
Erin D Mccaffery3 insp.
Lata C Mathew2 insp.
Maria Estrella2 insp.
Nicholas A Violand2 insp.
Betsy C Galliher1 insp.
Rose L Jean-Mary1 insp.
Alisha B Patel1 insp.
Rohan P Sridhar1 insp.
Russell J Glapion1 insp.
Robin P Mathew1 insp.
Emmanuel J Ramos1 insp.
Monika Borkowska1 insp.
Niketa Patel1 insp.
Nancy M Espinal1 insp.
Michael Serrano1 insp.
Luis A Dasta1 insp.
Constantin Y Philopoulos1 insp.
Dorothy J Denes1 insp.
Kristy A Zielny1 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 | 6x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(f) | 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 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.204 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind CorePharma, 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