PEL Healthcare LLC

FDA inspection history across 2 sites, 2018 to 2023

2
Form 483s

Every document, by year

  • Form 483

2018: one Form 483; 2023: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2018One Form 483, at SELLERSVILLE, Pennsylvania.
  2. 2023One Form 483, at Sellersville, Pennsylvania.
  3. 2023The longest 483 on file: 1 observation over 5 pages at Sellersville, Pennsylvania.

Cited most

Across all PEL Healthcare observations on file

The complete PEL Healthcare file.

All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.

$198

The price of the documents, added to your cart together

Sites

Documents

2 on file, newest first
DateDocumentPrice
2023-01-13483 Form 483$99
2018-04-24483 Form 483$99

Investigators on these documents

Anita R. Michael (1)Junho Pak (1)Ko U. Min (1)

FEI number 2517175 · most recent document Jan 13, 2023

About PEL Healthcare LLC

How many FDA Form 483s has PEL Healthcare LLC received?

FDA Intel has 2 Form 483s on file for PEL Healthcare LLC; the most recent is dated Jan 13, 2023.

When was PEL Healthcare LLC last inspected by FDA?

The most recent FDA inspection document on file for PEL Healthcare LLC is a Form 483 dated Jan 13, 2023, for the site in Sellersville, Pennsylvania.

What did FDA cite at PEL Healthcare LLC?

The regulations cited most in the observations on file for PEL Healthcare LLC are 21 CFR 211.192 (Production record review), 2 times.