Teva Puerto Rico LLC
Form 483 issued November 23, 2022 · Fajardo, Puerto Rico
- Inspection
- Nov 9 – Nov 23, 2022
- Investigator
- Libia M. Lugo
- Observations
- 2
- Pages
- 3
- FEI number
- 2619635
In short: On November 23, 2022, FDA issued a Form 483 with 2 observations to Teva Puerto Rico LLC in Fajardo, Puerto Rico (FEI 2619635) after an inspection that ran Nov 9 – Nov 23, 2022. The investigator was Libia M. Lugo. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.165 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established. Your laboratory areas…
- 02
There is a failure to thoroughly review the failure of a batch or any of its…
This inspection in context
Libia M. Lugo
24 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmTeva Puerto Rico 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 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Teva Puerto Rico LLC?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and quality system. 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 Teva Puerto Rico LLC?
Libia M. Lugo is named on this Form 483, for the inspection of Nov 9 – Nov 23, 2022. Each investigator has a profile showing what they cite most.
When was Teva Puerto Rico LLC inspected by FDA?
The inspection ran Nov 9 – Nov 23, 2022, and the Form 483 is dated November 23, 2022.
How do I get the full Form 483 for Teva Puerto Rico 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.