Teva Parenteral Medicines, Inc.
Form 483 issued June 4, 2013 · Irvine, California
- Inspection
- May 29 – Jun 4, 2013
- Investigator
- Marcus F. Yambot
- Observations
- 1
- Pages
- 1
- FEI number
- 2027158
In short: On June 4, 2013, FDA issued a Form 483 with 1 observation to Teva Parenteral Medicines, Inc. in Irvine, California (FEI 2027158) after an inspection that ran May 29 – Jun 4, 2013. The investigator was Marcus F. Yambot. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.100 (standard operating procedures).
At a glance
1 of 1 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 606.100(c) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Failure to perform a thorough investigation…
This inspection in context
Marcus F. Yambot
16 documents · 2009–2023
Cites 820.30 (design controls) 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 606.100(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Teva Parenteral Medicines, Inc.?
FDA listed 1 observation on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.100 (standard operating procedures). The opening words of each observation are shown on this page.
Who inspected Teva Parenteral Medicines, Inc.?
Marcus F. Yambot is named on this Form 483, for the inspection of May 29 – Jun 4, 2013. Each investigator has a profile showing what they cite most.
When was Teva Parenteral Medicines, Inc. inspected by FDA?
The inspection ran May 29 – Jun 4, 2013, and the Form 483 is dated June 4, 2013.
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.