Endo USA, Inc.
Form 483 issued July 20, 2021 · Rochester, Michigan
- Inspection
- Jul 14 – Jul 20, 2021
- Investigator
- Joseph A. Piechocki
- Observations
- 2
- Pages
- 3
- FEI number
- 1818977
In short: On July 20, 2021, FDA issued a Form 483 with 2 observations to Endo USA, Inc. in Rochester, Michigan (FEI 1818977) after an inspection that ran Jul 14 – Jul 20, 2021. The investigator was Joseph A. Piechocki. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.110 (1×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
The responsibilities and procedures applicable to the quality unit are not in writing…
This inspection in context
Joseph A. Piechocki
19 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmEndo USA, Inc. history
All 8 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Endo USA, Inc.?
FDA listed 2 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Endo USA, Inc.?
Joseph A. Piechocki is named on this Form 483, for the inspection of Jul 14 – Jul 20, 2021. Each investigator has a profile showing what they cite most.
When was Endo USA, Inc. inspected by FDA?
The inspection ran Jul 14 – Jul 20, 2021, and the Form 483 is dated July 20, 2021.
How do I get the full Form 483 for Endo USA, Inc.?
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.