Endo USA, Inc.
Form 483 issued July 23, 2015 · Rochester, Michigan
- Inspection
- Mar 13, 2012 – Mar 29, 2020
- Investigators
- Rebecca E. Dombrowski· Sarah M. Napier
- Observations
- 3
- Pages
- 6
- FEI number
- 1818977
In short: On July 23, 2015, FDA issued a Form 483 with 3 observations to Endo USA, Inc. in Rochester, Michigan (FEI 1818977) after an inspection that ran Mar 13, 2012 – Mar 29, 2020. The investigators were Rebecca E. Dombrowski and Sarah M. Napier. Most observations concern quality system and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies do not always include…
- 02
The responsibilities and procedures applicable to the quality control unit are not in writing…
- 03
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
This inspection in context
Rebecca E. Dombrowski
14 documents · 2006–2019
Cites 211.192 (production record review) 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 3 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Endo USA, Inc.?
Rebecca E. Dombrowski and Sarah M. Napier are named on this Form 483, for the inspection of Mar 13, 2012 – Mar 29, 2020. Each investigator has a profile showing what they cite most.
When was Endo USA, Inc. inspected by FDA?
The inspection ran Mar 13, 2012 – Mar 29, 2020, and the Form 483 is dated July 23, 2015.
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.