Bentley Laboratories, LLC
Form 483 issued March 16, 2026 · Edison, New Jersey
- Inspection
- Mar 16, 2026
- Investigators
- Annes Rayan· Stepheniz Mr Om· Umeplinc M. Ones
- Observations
- 1
- Pages
- 10
- FEI number
- 2244819
In short: On March 16, 2026, FDA issued a Form 483 with 1 observation to Bentley Laboratories, LLC in Edison, New Jersey (FEI 2244819) after an inspection that ran Mar 16, 2026. The investigators were Annes Rayan, Stepheniz Mr Om and Umeplinc M. Ones. Most observations concern materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
This inspection in context
Annes Rayan
1 document · 2026
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in New Jersey.
The firmBentley Laboratories, LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bentley Laboratories, LLC?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Bentley Laboratories, LLC?
Annes Rayan, Stepheniz Mr Om and Umeplinc M. Ones are named on this Form 483, for the inspection of Mar 16, 2026. Each investigator has a profile showing what they cite most.
When was Bentley Laboratories, LLC inspected by FDA?
The inspection ran Mar 16, 2026, and the Form 483 is dated March 16, 2026.
How do I get the full Form 483 for Bentley Laboratories, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.