Teva Puerto Rico LLC
Form 483 issued March 3, 2017 · Fajardo, Puerto Rico
- Inspection
- Feb 13, 2011 – Mar 3, 2017
- Observations
- 2
- Pages
- 3
- FEI number
- 2619635
In short: On March 3, 2017, FDA issued a Form 483 with 2 observations to Teva Puerto Rico LLC in Fajardo, Puerto Rico (FEI 2619635) after an inspection that ran Feb 13, 2011 – Mar 3, 2017. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written production and process control procedures are not followed in the execution of production…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
This inspection in context
Questions about this 483
What did FDA find at Teva Puerto Rico LLC?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
When was Teva Puerto Rico LLC inspected by FDA?
The inspection ran Feb 13, 2011 – Mar 3, 2017, and the Form 483 is dated March 3, 2017.
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.