Teva Parenteral Medicines, Inc.
Form 483 issued August 30, 2019 · Irvine, California
- Inspection
- Aug 26 – Aug 30, 2019
- Investigator
- Linda F. Murphy
- Observations
- 6
- Pages
- 4
- FEI number
- 2027158
In short: On August 30, 2019, FDA issued a Form 483 with 6 observations to Teva Parenteral Medicines, Inc. in Irvine, California (FEI 2027158) after an inspection that ran Aug 26 – Aug 30, 2019. The investigator was Linda F. Murphy. Most observations concern quality system and production.
At a glance
Quality system and production account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Employees engaged in the manufacture and processing of a drug product lack the training required to…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Linda F. Murphy
23 documents · 2015–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in India.
The firmTeva Parenteral Medicines, Inc. history
All 9 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 314.81
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Teva Parenteral Medicines, Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Teva Parenteral Medicines, Inc.?
Linda F. Murphy is named on this Form 483, for the inspection of Aug 26 – Aug 30, 2019. Each investigator has a profile showing what they cite most.
When was Teva Parenteral Medicines, Inc. inspected by FDA?
The inspection ran Aug 26 – Aug 30, 2019, and the Form 483 is dated August 30, 2019.
How do I get the full Form 483 for Teva Parenteral Medicines, 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.