A.P. Deauville, LLC
Form 483 issued May 2, 2019 · New Brunswick, New Jersey
- Inspection
- Apr 9 – May 2, 2019
- Investigator
- Adetutu Gidado
- Observations
- 14
- Pages
- 16
- FEI number
- 3004007943
In short: On May 2, 2019, FDA issued a Form 483 with 14 observations to A.P. Deauville, LLC in New Brunswick, New Jersey (FEI 3004007943) after an inspection that ran Apr 9 – May 2, 2019. The investigator was Adetutu Gidado. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 9 of 14 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures describing the handling of written and oral complaints related to drug products are…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Employees are not given training in the particular operations they perform as…
- 04
Control procedures are not established which validate the performance of those manufacturing processes that may be…
This inspection in context
Adetutu Gidado
16 documents · 2016–2025
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New Jersey.
The firmA.P. Deauville, 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 211.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at A.P. Deauville, LLC?
FDA listed 14 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected A.P. Deauville, LLC?
Adetutu Gidado is named on this Form 483, for the inspection of Apr 9 – May 2, 2019. Each investigator has a profile showing what they cite most.
When was A.P. Deauville, LLC inspected by FDA?
The inspection ran Apr 9 – May 2, 2019, and the Form 483 is dated May 2, 2019.
How do I get the full Form 483 for A.P. Deauville, 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.