Teva Pharmaceuticals USA, Inc.
Form 483 issued February 1, 2017 · Fairfield, New Jersey
- Inspection
- Jan 23 – Feb 1, 2017
- Investigators
- Helen Verdel· Niketa Patel
- Observations
- 3
- Pages
- 3
- FEI number
- 2245641
In short: On February 1, 2017, FDA issued a Form 483 with 3 observations to Teva Pharmaceuticals USA, Inc. in Fairfield, New Jersey (FEI 2245641) after an inspection that ran Jan 23 – Feb 1, 2017. The investigators were Helen Verdel and Niketa Patel. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
- 03
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
This inspection in context
Helen Verdel
13 documents · 2015–2023
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New Jersey.
The firmTeva Pharmaceuticals USA, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Teva Pharmaceuticals USA, Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Teva Pharmaceuticals USA, Inc.?
Helen Verdel and Niketa Patel are named on this Form 483, for the inspection of Jan 23 – Feb 1, 2017. Each investigator has a profile showing what they cite most.
When was Teva Pharmaceuticals USA, Inc. inspected by FDA?
The inspection ran Jan 23 – Feb 1, 2017, and the Form 483 is dated February 1, 2017.
How do I get the full Form 483 for Teva Pharmaceuticals USA, 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.