Teva Puerto Rico LLC
Form 483 issued March 6, 2015 · Fajardo, Puerto Rico
- Inspection
- Feb 18 – Mar 6, 2015
- Investigators
- Ariel Cruz Figueroa· Cassandra L. Abellard· Jose E. Melendez
- Observations
- 2
- Pages
- 2
- FEI number
- 2619635
In short: On March 6, 2015, 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 18 – Mar 6, 2015. The investigators were Ariel Cruz Figueroa, Cassandra L. Abellard and Jose E. Melendez. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.22(d) (1×) · 211.186(b)(9) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not folly followed. Your Quality…
- 02
Observation 2: scanned text, readable in the full document.
This inspection in context
Ariel Cruz Figueroa
16 documents · 2015–2023
Cites 211.22 (responsibilities of quality control unit) 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 211.22(d)
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 quality system and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Teva Puerto Rico LLC?
Ariel Cruz Figueroa, Cassandra L. Abellard and Jose E. Melendez are named on this Form 483, for the inspection of Feb 18 – Mar 6, 2015. Each investigator has a profile showing what they cite most.
When was Teva Puerto Rico LLC inspected by FDA?
The inspection ran Feb 18 – Mar 6, 2015, and the Form 483 is dated March 6, 2015.
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.