Endo USA, Inc.
Form 483 issued October 23, 2018 · Cranbury, New Jersey
- Inspection
- Oct 10 – Oct 23, 2018
- Investigators
- Adetutu Gidado· Maria E. Estrella
- Observations
- 5
- Pages
- 6
- FEI number
- 2243842
In short: On October 23, 2018, FDA issued a Form 483 with 5 observations to Endo USA, Inc. in Cranbury, New Jersey (FEI 2243842) after an inspection that ran Oct 10 – Oct 23, 2018. The investigators were Adetutu Gidado and Maria E. Estrella. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
Laboratory records are deficient in that they do not include a complete record of all data…
This inspection in context
Adetutu Gidado
16 documents · 2016–2025
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New Jersey.
The firmEndo USA, Inc. history
All 2 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 5 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Endo USA, Inc.?
Adetutu Gidado and Maria E. Estrella are named on this Form 483, for the inspection of Oct 10 – Oct 23, 2018. Each investigator has a profile showing what they cite most.
When was Endo USA, Inc. inspected by FDA?
The inspection ran Oct 10 – Oct 23, 2018, and the Form 483 is dated October 23, 2018.
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.