Teva Parenteral Medicines, Inc.
Form 483 issued July 24, 2009 · . Irvine, California
- Inspection
- Jul 13 – Jul 24, 2009
- Investigators
- Binh T. Nguyen· Joey V. Quitania· Kham Phommachanh
- Observations
- 14
- Pages
- 10
- FEI number
- 2027158
In short: On July 24, 2009, FDA issued a Form 483 with 14 observations to Teva Parenteral Medicines, Inc. in . Irvine, California (FEI 2027158) after an inspection that ran Jul 13 – Jul 24, 2009. The investigators were Binh T. Nguyen, Joey V. Quitania, Kham Phommachanh and Thomas J. Arista. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.192 (3×)
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
In-process materials are not tested for quality and purity and approved or rejected by the quality…
- 04
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate…
This inspection in context
Binh T. Nguyen
13 documents · 2009–2016
Cites 211.42 (design and construction features) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Teva Parenteral Medicines, Inc.?
FDA listed 14 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Teva Parenteral Medicines, Inc.?
Binh T. Nguyen, Joey V. Quitania, Kham Phommachanh and Thomas J. Arista are named on this Form 483, for the inspection of Jul 13 – Jul 24, 2009. Each investigator has a profile showing what they cite most.
When was Teva Parenteral Medicines, Inc. inspected by FDA?
The inspection ran Jul 13 – Jul 24, 2009, and the Form 483 is dated July 24, 2009.
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.