Bentley Laboratories, LLC
Form 483 issued August 17, 2022 · Edison, New Jersey
- Inspection
- Aug 8 – Aug 17, 2022
- Investigators
- Anthony Donato· Monika Borkowska
- Observations
- 3
- Pages
- 5
- FEI number
- 2244819
In short: On August 17, 2022, FDA issued a Form 483 with 3 observations to Bentley Laboratories, LLC in Edison, New Jersey (FEI 2244819) after an inspection that ran Aug 8 – Aug 17, 2022. The investigators were Anthony Donato and Monika Borkowska. Most observations concern production and laboratory controls.
At a glance
2 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 02
The batch production and control records are deficient in that they do not include identification of…
- 03
Sampling and testing plans for drug products are not described in written procedures which include the…
This inspection in context
Anthony Donato
6 documents · 2020–2026
Cites 211.22 (responsibilities of quality control unit) 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 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bentley Laboratories, LLC?
FDA listed 3 observations on this Form 483, mostly about production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Bentley Laboratories, LLC?
Anthony Donato and Monika Borkowska are named on this Form 483, for the inspection of Aug 8 – Aug 17, 2022. Each investigator has a profile showing what they cite most.
When was Bentley Laboratories, LLC inspected by FDA?
The inspection ran Aug 8 – Aug 17, 2022, and the Form 483 is dated August 17, 2022.
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.