Bentley Laboratories, LLC
FDA inspection history in Edison, New Jersey, 2022 to 2026
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2022: one Form 483; 2026: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at Edison, New Jersey.
- 2022The longest 483 on file: 3 observations over 5 pages at Edison, New Jersey.
- 2026One warning letter and one Form 483, at Edison, New Jersey.
Cited most
Across all Bentley Laboratories observations on file
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.165(c)Testing and release for distribution1
- 21 CFR 211.188(b)(11)Batch production and control records1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete Bentley Laboratories file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Edison, New Jersey
Two Form 483s and one warning letter · 2022 to 2026 · 4 observations
Latest: Warning letter, Sep 17, 2026 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-09-17 | Warning letter Warning letter | Edison, New Jersey | — | $99 |
| 2026-03-16 | 483 Form 483 | Edison, New Jersey | 1 | $99 |
| 2022-08-17 | 483 Form 483 | Edison, New Jersey | 3 | $99 |
Investigators on these documents
Annes Rayan (1)Anthony Donato (1)Monika Borkowska (1)Stepheniz Mr Om (1)Umeplinc M. Ones (1)
FEI number 2244819 · most recent document Sep 17, 2026
About Bentley Laboratories, LLC
How many FDA Form 483s has Bentley Laboratories, LLC received?
FDA Intel has 2 Form 483s on file for Bentley Laboratories, LLC; the most recent is dated Mar 16, 2026.
When was Bentley Laboratories, LLC last inspected by FDA?
The most recent FDA inspection document on file for Bentley Laboratories, LLC is a Form 483 dated Mar 16, 2026, for the site in Edison, New Jersey.
What did FDA cite at Bentley Laboratories, LLC?
The regulations cited most in the observations on file for Bentley Laboratories, LLC are 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.165(c) (Testing and release for distribution), 1 time; 21 CFR 211.188(b)(11) (Batch production and control records), 1 time.
Has Bentley Laboratories, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Bentley Laboratories, LLC; the most recent is dated Sep 17, 2026.