Endo USA, Inc.
Form 483 issued December 28, 2012 · Rochester, Michigan
- Inspection
- Dec 12 – Dec 28, 2012
- Investigators
- Emily J. Orban· Michele L. Forster· Rebecca E. Dombrowski
- Observations
- 2
- Pages
- 3
- FEI number
- 1818977
In short: On December 28, 2012, FDA issued a Form 483 with 2 observations to Endo USA, Inc. in Rochester, Michigan (FEI 1818977) after an inspection that ran Dec 12 – Dec 28, 2012. The investigators were Emily J. Orban, Michele L. Forster and Rebecca E. Dombrowski. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Emily J. Orban
19 documents · 2012–2020
Cites 211.42 (design and construction features) 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 211.192
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 quality system 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.?
Emily J. Orban, Michele L. Forster and Rebecca E. Dombrowski are named on this Form 483, for the inspection of Dec 12 – Dec 28, 2012. Each investigator has a profile showing what they cite most.
When was Endo USA, Inc. inspected by FDA?
The inspection ran Dec 12 – Dec 28, 2012, and the Form 483 is dated December 28, 2012.
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.