Overview
- 32 FDA inspections are on record.
- 14 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-06-16.
At a glance
Inspections
32
Form 483s
14
EIRs
4
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Jun 2023 – 16 Jun 2023 | Human Drugs | 483 | View 483 → |
| 11 May 2021 – 20 May 2021 | Biologics | 483 | On file |
| 26 Nov 2018 – 10 Dec 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 10 Sep 2018 – 21 Sep 2018 | Human Drugs | 483 | View 483 → |
| 18 Dec 2017 – 22 Dec 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 30 Oct 2017 – 7 Nov 2017 | Biologics | 483 | On file |
| 3 Nov 2015 – 12 Nov 2015 | Biologics | Clean | |
| 23 Jun 2015 – 9 Jul 2015 | Human Drugs | 483 | On file |
| 19 Feb 2014 – 28 Feb 2014 | Biologics | 483 | On file |
| 10 Jun 2013 – 20 Jun 2013 | Human Drugs | 483 | On file |
| 29 Aug 2012 | Not recorded | 483 | On file |
| 23 Sep 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Jun 2023
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Gene D Arcy, Michele Perry-Williams, Jacob G Lutz
16 Jun 2023
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Gene D Arcy, Michele Perry-Williams, Jacob G Lutz
16 Jun 2023
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Gene D Arcy, Michele Perry-Williams, Jacob G Lutz
16 Jun 2023
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Gene D Arcy, Michele Perry-Williams, Jacob G Lutz
16 Jun 2023
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Gene D Arcy, Michele Perry-Williams, Jacob G Lutz
Investigators
FDA investigators tied to this site in the record.
Emily J Orban4 insp.
Rebecca E Dombrowski4 insp.
Michele L Forster3 insp.
Martha Sullivan Myrick3 insp.
Thomas A Peter2 insp.
Jeffrey D Meng2 insp.
Andrew J Idzior2 insp.
Christian Lynch2 insp.
Gene D Arcy1 insp.
Michele Perry-Williams1 insp.
Jacob G Lutz1 insp.
Brentley S Collins1 insp.
Prabhu P Raju1 insp.
Janet L Bowen1 insp.
David J Gasparovich1 insp.
Sarah E Rhoades1 insp.
James K Ireland1 insp.
Scott A Golladay1 insp.
Matthew J Gretkierewicz1 insp.
Susan M Jackson1 insp.
Mihaly S Ligmond1 insp.
Robert M Barbosa1 insp.
Geneve M Parks1 insp.
Philip A Klimkewicz1 insp.
Sanket N Patel1 insp.
Sarah M Napier1 insp.
Helen B Ricalde1 insp.
Paula A Trost1 insp.
Patsy J Domingo1 insp.
Daniel J Brown1 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 | 6x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Pharmacia & Upjohn Company LLC's 14 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