Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-29.
At a glance
Inspections
7
Form 483s
4
EIRs
4
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Apr 2026 – 29 Apr 2026 | Biologics | 483 | View 483 → |
| 5 Sep 2023 – 25 Sep 2023 | Biologics | 483 | View 483 → |
| 17 Jun 2021 – 25 Jun 2021 | Biologics | Clean | |
| 20 Aug 2018 – 28 Aug 2018 | Biologics | Clean | |
| 2 Mar 2016 – 25 Mar 2016 | Biologics | Clean | |
| 17 Feb 2012 | Not recorded | 483 | View 483 → |
| 31 Jul 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Apr 2026
21 CFR 1271.150(c)(1)(iii)
Ensurane of compliance
Cited by Shelley H Beausoleil, Conor J Mccarron
29 Apr 2026
21 CFR 1271.160(b)(6)
Deviations--evaluation, cause, corrective action
Cited by Shelley H Beausoleil, Conor J Mccarron
29 Apr 2026
21 CFR 1271.195(a)
Adequate control, proper conditions
Cited by Shelley H Beausoleil, Conor J Mccarron
29 Apr 2026
21 CFR 1271.210(a)
Use prior to verification
Cited by Shelley H Beausoleil, Conor J Mccarron
29 Apr 2026
21 CFR 1271.47(a)
Design of procedures to ensure compliance
Cited by Shelley H Beausoleil, Conor J Mccarron
Investigators
FDA investigators tied to this site in the record.
Shelley H Beausoleil4 insp.
Conor J Mccarron1 insp.
Tania Y Hall1 insp.
Richard L Bartlett1 insp.
Ka L Wong1 insp.
Seyyida Saterfield1 insp.
Laverne Puckett1 insp.
Roger D Gawne1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.230(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.75(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.150(c)(1)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.160(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.210(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.260(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Berkeley Biologics LLC'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