Teva Parenteral Medicines, Inc.
Form 483 issued August 20, 2021 · Irvine, California
- Inspection
- Jul 21 – Aug 20, 2021
- Investigators
- Amir Alavi· Sangeeta M. Khurana· Santiago Gallardo Johnson
- Observations
- 10
- Pages
- 25
- FEI number
- 2027158
In short: On August 20, 2021, FDA issued a Form 483 with 10 observations to Teva Parenteral Medicines, Inc. in Irvine, California (FEI 2027158) after an inspection that ran Jul 21 – Aug 20, 2021. The investigators were Amir Alavi, Sangeeta M. Khurana and Santiago Gallardo Johnson. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 6 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or…
- 02
Control procedures are not established which monitor the output of those manufacturing processes that may be…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
This inspection in context
Amir Alavi
9 documents · 2017–2024
Cites 211.113 (control of microbiological contamination) 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 10 observations on this Form 483, mostly about production, facilities & equipment and quality system. 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.?
Amir Alavi, Sangeeta M. Khurana and Santiago Gallardo Johnson are named on this Form 483, for the inspection of Jul 21 – Aug 20, 2021. Each investigator has a profile showing what they cite most.
When was Teva Parenteral Medicines, Inc. inspected by FDA?
The inspection ran Jul 21 – Aug 20, 2021, and the Form 483 is dated August 20, 2021.
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.