Endo USA, Inc.
Form 483 issued March 13, 2017 · Rochester, Michigan
- Inspection
- Feb 15 – Mar 13, 2017
- Investigators
- Bei Y. He· Emilie Kahn· Emily J. Orban
- Observations
- 1
- Pages
- 4
- FEI number
- 1818977
In short: On March 13, 2017, FDA issued a Form 483 with 1 observation to Endo USA, Inc. in Rochester, Michigan (FEI 1818977) after an inspection that ran Feb 15 – Mar 13, 2017. The investigators were Bei Y. He, Emilie Kahn and Emily J. Orban. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Bei Y. He
14 documents · 2016–2025
Cites 211.113 (control of microbiological contamination) 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 211.22(d)
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 quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Endo USA, Inc.?
Bei Y. He, Emilie Kahn and Emily J. Orban are named on this Form 483, for the inspection of Feb 15 – Mar 13, 2017. Each investigator has a profile showing what they cite most.
When was Endo USA, Inc. inspected by FDA?
The inspection ran Feb 15 – Mar 13, 2017, and the Form 483 is dated March 13, 2017.
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.