PEL Healthcare LLC
Form 483 issued April 24, 2018 · SELLERSVILLE, Pennsylvania
- Inspection
- Apr 9 – Apr 24, 2018
- Investigator
- Anita R. Michael
- Observations
- 1
- Pages
- 2
- FEI number
- 2517175
In short: On April 24, 2018, FDA issued a Form 483 with 1 observation to PEL Healthcare LLC in SELLERSVILLE, Pennsylvania (FEI 2517175) after an inspection that ran Apr 9 – Apr 24, 2018. The investigator was Anita R. Michael. 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 observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Anita R. Michael
18 documents · 2006–2020
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
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?
Anita R. Michael is named on this Form 483, for the inspection of Apr 9 – Apr 24, 2018. Each investigator has a profile showing what they cite most.
When was PEL Healthcare LLC inspected by FDA?
The inspection ran Apr 9 – Apr 24, 2018, and the Form 483 is dated April 24, 2018.
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.