Teva Parenteral Medicines, Inc.
Form 483 issued May 14, 2010 · Irvine, California
- Inspection
- May 7 – May 14, 2010
- Observations
- 1
- Pages
- 28
- FEI number
- 2027158
In short: On May 14, 2010, FDA issued a Form 483 with 1 observation to Teva Parenteral Medicines, Inc. in Irvine, California (FEI 2027158) after an inspection that ran May 7 – May 14, 2010. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×) · 211.63 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 02
Observation 2: scanned text, readable in the full document.
This inspection in context
Questions about this 483
What did FDA find at Teva Parenteral Medicines, Inc.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
When was Teva Parenteral Medicines, Inc. inspected by FDA?
The inspection ran May 7 – May 14, 2010, and the Form 483 is dated May 14, 2010.
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.