Overview
- 13 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-07-18.
At a glance
Inspections
13
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Jul 2025 – 18 Jul 2025 | Human Drugs | 483 | On file |
| 24 May 2023 – 1 Jun 2023 | Human Drugs | 483 | View 483 → |
| 8 Mar 2018 – 19 Mar 2018 | Human Drugs | 483 | View 483 → |
| 21 Feb 2018 – 22 Feb 2018 | Medical Devices & Rad Health | Clean | |
| 25 Oct 2017 – 27 Oct 2017 | Human Drugs | Clean | |
| 23 Oct 2013 – 30 Oct 2013 | Human Drugs | 483 | On file |
| 5 Aug 2013 – 9 Aug 2013 | Human Drugs | Clean | |
| 19 Oct 2010 | Not recorded | Clean | |
| 24 May 2010 | Not recorded | Clean | |
| 18 Sep 2009 | Not recorded | Clean | |
| 13 Mar 2008 | Not recorded | Clean | |
| 27 Feb 2006 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Jun 2023
21 CFR 211.160(b)(4)
Establishment of calibration procedures
Cited by Jolanna A Norton, Matthew R Clabeaux
1 Jun 2023
21 CFR 211.192
Written record of investigation incomplete
Cited by Jolanna A Norton, Matthew R Clabeaux
1 Jun 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jolanna A Norton, Matthew R Clabeaux
Investigators
FDA investigators tied to this site in the record.
Stuart W Russell3 insp.
Daniel J Roberts2 insp.
Scott N Lim1 insp.
Andrew R Wasko1 insp.
Jolanna A Norton1 insp.
Matthew R Clabeaux1 insp.
Ashar P Parikh1 insp.
Dustin P Tran1 insp.
Eileen A Liu1 insp.
Alicia K Mckinsey1 insp.
Evelyn Wong1 insp.
Peter E Baker1 insp.
Jeffrey M Watson1 insp.
Kevin P Foley1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b)(4) | 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 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Pacific BioLabs, Inc.'s 4 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