Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-27.
At a glance
Inspections
7
Form 483s
6
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Mar 2026 – 27 Mar 2026 | Human Drugs | 483 | On file |
| 8 Aug 2022 – 17 Aug 2022 | Human Drugs | 483 | View 483 → |
| 5 Jun 2017 – 9 Jun 2017 | Human Drugs | 483 | On file |
| 18 Aug 2014 – 2 Sep 2014 | Human Drugs | 483 | On file |
| 30 Jan 2012 | Not recorded | 483 | View 483 → |
| 17 Nov 2009 | Not recorded | 483 | View 483 → |
| 7 Mar 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Aug 2022
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Monika Borkowska, Anthony J Donato
17 Aug 2022
21 CFR 211.165(c)
Sampling and testing plans not described
Cited by Monika Borkowska, Anthony J Donato
17 Aug 2022
21 CFR 211.188(b)(11)
Identification of Persons Performing Significant Steps
Cited by Monika Borkowska, Anthony J Donato
30 Jan 2012
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Nicholas A Violand, Juanita P Versace, Addam S Reynolds, Eufemia G Gonzalez
30 Jan 2012
21 CFR 211.28(a)
Protective Apparel Not Worn
Cited by Nicholas A Violand, Juanita P Versace, Addam S Reynolds, Eufemia G Gonzalez
Investigators
FDA investigators tied to this site in the record.
Frederick Razzaghi2 insp.
Addam S Reynolds2 insp.
Annet R Rajan1 insp.
Stephenie M Ortiz1 insp.
Monika Borkowska1 insp.
Anthony J Donato1 insp.
Jay T Wong1 insp.
Nicholas A Violand1 insp.
Juanita P Versace1 insp.
Eufemia G Gonzalez1 insp.
Meredith L Sheridan1 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 211.115(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(11) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(c)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bentley Laboratories LLC'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