Epicare Acquisitions, Lie
Form 483 issued December 13, 2024 · Lawrenceville, New Jersey
- Inspection
- Nov 12 – Dec 13, 2024
- Investigator
- William R. Chang
- Observations
- 10
- Pages
- 13
- FEI number
- 3015730775
In short: On December 13, 2024, FDA issued a Form 483 with 10 observations to Epicare Acquisitions, Lie in Lawrenceville, New Jersey (FEI 3015730775) after an inspection that ran Nov 12 – Dec 13, 2024. The investigator was William R. Chang. Most observations concern records & documents and cAPA.
At a glance
Observations span 4 systems, led by records & documents.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design validation have…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 03
Procedures for corrective and preventive action have…
- 04
The information required by the Global Unique Device Identification Database for each medical device version or…
This inspection in context
William R. Chang
5 documents · 2019–2025
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in New Jersey.
The firmEpicare Acquisitions, Lie history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Epicare Acquisitions, Lie?
FDA listed 10 observations on this Form 483, mostly about records & documents, cAPA and design controls. The opening words of each observation are shown on this page.
Who inspected Epicare Acquisitions, Lie?
William R. Chang is named on this Form 483, for the inspection of Nov 12 – Dec 13, 2024. Each investigator has a profile showing what they cite most.
When was Epicare Acquisitions, Lie inspected by FDA?
The inspection ran Nov 12 – Dec 13, 2024, and the Form 483 is dated December 13, 2024.
How do I get the full Form 483 for Epicare Acquisitions, Lie?
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.