Endo USA, Inc.
Form 483 issued April 15, 2019 · Rochester, Michigan
- Inspection
- Apr 8 – Apr 15, 2019
- Investigators
- Amy S. Graf· Joseph T. Madak· Sarah E. Rhoades
- Observations
- 1
- Pages
- 2
- FEI number
- 1818977
In short: On April 15, 2019, FDA issued a Form 483 with 1 observation to Endo USA, Inc. in Rochester, Michigan (FEI 1818977) after an inspection that ran Apr 8 – Apr 15, 2019. The investigators were Amy S. Graf, Joseph T. Madak, Sarah E. Rhoades and Shirshendu K. Deb. Most observations concern production; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.188(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The batch production and control records are deficient in that they do not include documentation of…
This inspection in context
Amy S. Graf
3 documents · 2016–2019
Cites 820.198(a) (complaint files) 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 211.188(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 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected Endo USA, Inc.?
Amy S. Graf, Joseph T. Madak, Sarah E. Rhoades and Shirshendu K. Deb are named on this Form 483, for the inspection of Apr 8 – Apr 15, 2019. Each investigator has a profile showing what they cite most.
When was Endo USA, Inc. inspected by FDA?
The inspection ran Apr 8 – Apr 15, 2019, and the Form 483 is dated April 15, 2019.
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.