Overview
- 25 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-10-31.
At a glance
Inspections
25
Form 483s
7
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Oct 2024 – 31 Oct 2024 | Human Drugs | Clean | |
| 2 Jan 2024 – 12 Jan 2024 | Human Drugs | Clean | |
| 10 May 2023 – 16 May 2023 | Human Drugs | Clean | |
| 2 Nov 2022 – 10 Nov 2022 | Human Drugs | Clean | |
| 21 Jul 2021 – 2 Aug 2021 | Human Drugs | Clean | |
| 6 Jan 2020 – 5 Feb 2020 | Human Drugs | 483 | View 483 → |
| 13 Aug 2018 – 17 Aug 2018 | Human Drugs | 483 | View 483 → |
| 31 Oct 2017 – 8 Nov 2017 | Human Drugs | Clean | |
| 6 Jul 2017 – 12 Jul 2017 | Human Drugs | Clean | |
| 29 Sep 2016 – 5 Oct 2016 | Human Drugs | Clean | |
| 29 Oct 2015 – 3 Nov 2015 | Human Drugs | Clean | |
| 24 Feb 2014 – 18 Mar 2014 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Feb 2020
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by James R Birkenstamm, Patric C Klotzbuecher, Rose L Jean-Mary
5 Feb 2020
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by James R Birkenstamm, Patric C Klotzbuecher, Rose L Jean-Mary
5 Feb 2020
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by James R Birkenstamm, Patric C Klotzbuecher, Rose L Jean-Mary
17 Aug 2018
21 CFR 211.192
Written record of investigation incomplete
Cited by Jogy George, Cassandra L Abellard
17 Aug 2018
21 CFR 211.192
Written record of investigation incomplete
Cited by Jogy George, Cassandra L Abellard
Investigators
FDA investigators tied to this site in the record.
Paul L Bellamy3 insp.
Jose M Cayuela3 insp.
Adetutu M Gidado2 insp.
Atul Agrawal2 insp.
Michael R Klapal2 insp.
Lauren L Vajo2 insp.
Addam S Reynolds2 insp.
Helen Verdel1 insp.
Jessica S Estriplet1 insp.
Stephenie M Ortiz1 insp.
Suchan Kim1 insp.
Jenny Sung1 insp.
Satheesh K Podaralla1 insp.
Janet A Rajan1 insp.
Victoria Spivak1 insp.
Samir C Gala1 insp.
Guerlain Ulysse1 insp.
James R Birkenstamm1 insp.
Patric C Klotzbuecher1 insp.
Rose L Jean-Mary1 insp.
Jogy George1 insp.
Cassandra L Abellard1 insp.
Melissa T Roy1 insp.
Nancy F Scheraga1 insp.
Frederick Razzaghi1 insp.
Russell J Glapion1 insp.
Alberto A Viciedo1 insp.
Justine Tomasso1 insp.
Douglas C Kovacs1 insp.
Nicholas A Violand1 insp.
Daniel J Grabicki1 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 | 4x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | 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 Ohm Laboratories 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