Teva Parenteral Medicines, Inc.
Form 483 issued April 24, 2012 · Irvine, California
- Inspection
- Apr 3 – Apr 24, 2012
- Investigators
- Carla J. Lundi· Jennifer M. Gogley
- Observations
- 2
- Pages
- 3
- FEI number
- 2027158
In short: On April 24, 2012, FDA issued a Form 483 with 2 observations to Teva Parenteral Medicines, Inc. in Irvine, California (FEI 2027158) after an inspection that ran Apr 3 – Apr 24, 2012. The investigators were Carla J. Lundi and Jennifer M. Gogley. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42(c)(10)(iv) (1×) · 211.67(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would…
This inspection in context
Carla J. Lundi
9 documents · 2009–2021
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
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 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Teva Parenteral Medicines, Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Teva Parenteral Medicines, Inc.?
Carla J. Lundi and Jennifer M. Gogley are named on this Form 483, for the inspection of Apr 3 – Apr 24, 2012. Each investigator has a profile showing what they cite most.
When was Teva Parenteral Medicines, Inc. inspected by FDA?
The inspection ran Apr 3 – Apr 24, 2012, and the Form 483 is dated April 24, 2012.
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.