Endo USA, Inc.
Form 483 issued October 22, 2021 · Rochester, Michigan
- Inspection
- Oct 13 – Oct 22, 2021
- Investigators
- Lauren M. Lilly· Susan M. Jackson
- Observations
- 5
- Pages
- 3
- FEI number
- 1818977
In short: On October 22, 2021, FDA issued a Form 483 with 5 observations to Endo USA, Inc. in Rochester, Michigan (FEI 1818977) after an inspection that ran Oct 13 – Oct 22, 2021. The investigators were Lauren M. Lilly and Susan M. Jackson. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 4 of 5 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Written records of investigations into unexplained discrepancies do not always include the…
- 03
Reoccurring HEPA filter failures are not investigated and/or are not assigned a…
- 04
Hand washing facilities are…
This inspection in context
Lauren M. Lilly
5 documents · 2020–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Endo USA, Inc.?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and production. 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 Endo USA, Inc.?
Lauren M. Lilly and Susan M. Jackson are named on this Form 483, for the inspection of Oct 13 – Oct 22, 2021. Each investigator has a profile showing what they cite most.
When was Endo USA, Inc. inspected by FDA?
The inspection ran Oct 13 – Oct 22, 2021, and the Form 483 is dated October 22, 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.