In short: On January 13, 2023, FDA issued a Form 483 with 1 observation to PEL Healthcare LLC in Sellersville, Pennsylvania (FEI 2517175) after an inspection that ran Feb 19, 2022 – Jan 13, 2023. The investigators were Junho Pak and Ko U. Min. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Junho Pak
28 documents · 2012–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmPEL Healthcare LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PEL Healthcare LLC?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected PEL Healthcare LLC?
Junho Pak and Ko U. Min are named on this Form 483, for the inspection of Feb 19, 2022 – Jan 13, 2023. Each investigator has a profile showing what they cite most.
When was PEL Healthcare LLC inspected by FDA?
The inspection ran Feb 19, 2022 – Jan 13, 2023, and the Form 483 is dated January 13, 2023.
How do I get the full Form 483 for PEL Healthcare 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.