Endo USA, Inc.
Form 483 issued April 14, 2023 · Rochester, Michigan
- Inspection
- Apr 5 – Apr 14, 2023
- Investigator
- Jacob G. Lutz
- Observations
- 1
- Pages
- 4
- FEI number
- 1818977
In short: On April 14, 2023, FDA issued a Form 483 with 1 observation to Endo USA, Inc. in Rochester, Michigan (FEI 1818977) after an inspection that ran Apr 5 – Apr 14, 2023. The investigator was Jacob G. Lutz. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Jacob G. Lutz
14 documents · 2019–2024
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Michigan.
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Endo USA, Inc.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Endo USA, Inc.?
Jacob G. Lutz is named on this Form 483, for the inspection of Apr 5 – Apr 14, 2023. Each investigator has a profile showing what they cite most.
When was Endo USA, Inc. inspected by FDA?
The inspection ran Apr 5 – Apr 14, 2023, and the Form 483 is dated April 14, 2023.
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.