Teva Parenteral Medicines, Inc.
Form 483 issued July 29, 2016 · Irvine, California
- Inspection
- Jul 29, 2016
- Investigator
- A. Gregory A. Berg
- Observations
- 3
- Pages
- 2
- FEI number
- 2027158
In short: On July 29, 2016, FDA issued a Form 483 with 3 observations to Teva Parenteral Medicines, Inc. in Irvine, California (FEI 2027158) after an inspection that ran Jul 29, 2016. The investigator was A. Gregory A. Berg. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (2×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient in that walls are not smooth and/or hard surfaces…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Control procedures are not established which monitor the output of those manufacturing processes that may be…
This inspection in context
A. Gregory A. Berg
1 document · 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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Teva Parenteral Medicines, Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. 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.?
A. Gregory A. Berg is named on this Form 483, for the inspection of Jul 29, 2016. Each investigator has a profile showing what they cite most.
When was Teva Parenteral Medicines, Inc. inspected by FDA?
The inspection ran Jul 29, 2016, and the Form 483 is dated July 29, 2016.
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.