Teva Parenteral Medicines, Inc.
Form 483 issued January 18, 2019 · Irvine, California
- Inspection
- Jan 11 – Jan 18, 2019
- Investigators
- Adam R. Cooke· Amanda L. Fyles· Amir Alavi
- Observations
- 4
- Pages
- 5
- FEI number
- 2027158
In short: On January 18, 2019, FDA issued a Form 483 with 4 observations to Teva Parenteral Medicines, Inc. in Irvine, California (FEI 2027158) after an inspection that ran Jan 11 – Jan 18, 2019. The investigators were Adam R. Cooke, Amanda L. Fyles, Amir Alavi and Walden H. Lee. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and laboratory controls account for 4 of 4 observations.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Written production and process control procedures are not followed in the execution of production…
- 03
Established laboratory control mechanisms are not followed and documented at…
- 04
The accuracy, specificity and reproducibility of test methods…
This inspection in context
Adam R. Cooke
11 documents · 2015–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in North Carolina.
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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Teva Parenteral Medicines, Inc.?
FDA listed 4 observations on this Form 483, mostly about production and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Teva Parenteral Medicines, Inc.?
Adam R. Cooke, Amanda L. Fyles, Amir Alavi and Walden H. Lee are named on this Form 483, for the inspection of Jan 11 – Jan 18, 2019. Each investigator has a profile showing what they cite most.
When was Teva Parenteral Medicines, Inc. inspected by FDA?
The inspection ran Jan 11 – Jan 18, 2019, and the Form 483 is dated January 18, 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.