A.P. Deauville, LLC
Amended 483 issued February 20, 2025 · Easton, Pennsylvania
- Inspection
- Jan 13 – Jan 23, 2025
- Observations
- 11
- Pages
- 13
- FEI number
- 3004007943
In short: On February 20, 2025, FDA issued a Amended 483 with 11 observations to A.P. Deauville, LLC in Easton, Pennsylvania (FEI 3004007943) after an inspection that ran Jan 13 – Jan 23, 2025. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Written records are not made of investigations into unexplained discrepancies and the failure of a batch…
- 03
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 06
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
7 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Questions about this amended 483
What did FDA find at A.P. Deauville, LLC?
FDA listed 11 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
When was A.P. Deauville, LLC inspected by FDA?
The inspection ran Jan 13 – Jan 23, 2025, and the Amended 483 is dated February 20, 2025.
How do I get the full Amended 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.