Actavis Totowa, LLC
Form 483 issued October 11, 2006 · Totowa, New Jersey
- Inspection
- Oct 11, 2006
- Investigator
- Kristy A. Zielny
- Observations
- 3
- Pages
- 3
- FEI number
- 3003450194
In short: On October 11, 2006, FDA issued a Form 483 with 3 observations to Actavis Totowa, LLC in Totowa, New Jersey (FEI 3003450194) after an inspection that ran Oct 11, 2006. The investigator was Kristy A. Zielny. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
3 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Deviations from v,TÎtten specifications, test procedures, and laboratory…
- 02
The accuracy, sensitivity, specificity, and reproducibility of test methods…
- 03
Verification of the suitability of the testing methods is deficient in that they are not performed…
This inspection in context
Kristy A. Zielny
5 documents · 2006–2008
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in New Jersey.
The firmActavis Totowa, LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Actavis Totowa, LLC?
FDA listed 3 observations on this Form 483, mostly about laboratory controls. 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 Actavis Totowa, LLC?
Kristy A. Zielny is named on this Form 483, for the inspection of Oct 11, 2006. Each investigator has a profile showing what they cite most.
When was Actavis Totowa, LLC inspected by FDA?
The inspection ran Oct 11, 2006, and the Form 483 is dated October 11, 2006.
How do I get the full Form 483 for Actavis Totowa, LLC?
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.