Overview
- 13 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-02-23.
At a glance
Inspections
13
Form 483s
6
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Feb 2024 – 23 Feb 2024 | Human Drugs | 483 | View 483 → |
| 28 Oct 2019 – 30 Oct 2019 | Human Drugs | Clean | |
| 3 Sep 2019 – 6 Sep 2019 | Human Drugs | 483 | View 483 → |
| 21 Feb 2017 – 3 Mar 2017 | Human Drugs | 483 | View 483 → |
| 12 Dec 2013 – 20 Dec 2013 | Human Drugs | 483 | View 483 → |
| 23 May 2012 | Not recorded | Clean | |
| 7 Dec 2010 | Not recorded | Clean | |
| 15 Mar 2010 | Not recorded | 483 | View 483 → |
| 4 Aug 2009 | Not recorded | Clean | |
| 17 Feb 2009 | Not recorded | 483 | On file |
| 4 Dec 2008 | Not recorded | Clean | |
| 30 Jun 2008 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Feb 2024
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Bryan A Galvez, Wenzheng Zhang, Laurenee L Adeoshun
23 Feb 2024
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Bryan A Galvez, Wenzheng Zhang, Laurenee L Adeoshun
23 Feb 2024
21 CFR 211.165(a)
Testing and release for distribution
Cited by Bryan A Galvez, Wenzheng Zhang, Laurenee L Adeoshun
23 Feb 2024
21 CFR 211.165(d)
Acceptance criteria for sampling & testing
Cited by Bryan A Galvez, Wenzheng Zhang, Laurenee L Adeoshun
23 Feb 2024
21 CFR 211.180(e)
Records reviewed annually
Cited by Bryan A Galvez, Wenzheng Zhang, Laurenee L Adeoshun
Investigators
FDA investigators tied to this site in the record.
Caryn M Mcnab2 insp.
Uttaniti Limchumroon2 insp.
Cntrctmntr Kelley2 insp.
Bryan A Galvez1 insp.
Wenzheng Zhang1 insp.
Laurenee L Adeoshun1 insp.
Teresa I Navas1 insp.
Linda F Murphy1 insp.
Liming Zhang1 insp.
Carla J Lundi1 insp.
Kim L Thomas Cruse1 insp.
Linda Thai1 insp.
Lucas B Leake1 insp.
Virgilio F Pacio1 insp.
Steven E Porter1 insp.
Binh T Nguyen1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 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 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Forma Life Sciences, Inc'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