TAPI Puerto Rico Inc
Form 483 issued October 24, 2014 · Guayama, Puerto Rico
- Inspection
- Sep 30 – Oct 24, 2014
- Investigator
- Jose Velez
- Observations
- 3
- Pages
- 4
- FEI number
- 3001104764
In short: On October 24, 2014, FDA issued a Form 483 with 3 observations to TAPI Puerto Rico Inc in Guayama, Puerto Rico (FEI 3001104764) after an inspection that ran Sep 30 – Oct 24, 2014. The investigator was Jose Velez. Most observations concern quality system and production.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm lacks robust process controls to monitor and detect the source for the OOS results…
- 02
Your quality unit failed to evaluate, review, and approve adequate and meaningful methods for the release…
- 03
Your Quality unit failed to adequately investigate and consequently determine the route of action when out…
This inspection in context
Jose Velez
24 documents · 2014–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmTAPI Puerto Rico Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at TAPI Puerto Rico Inc?
FDA listed 3 observations on this Form 483, mostly about quality system and production. The opening words of each observation are shown on this page.
Who inspected TAPI Puerto Rico Inc?
Jose Velez is named on this Form 483, for the inspection of Sep 30 – Oct 24, 2014. Each investigator has a profile showing what they cite most.
When was TAPI Puerto Rico Inc inspected by FDA?
The inspection ran Sep 30 – Oct 24, 2014, and the Form 483 is dated October 24, 2014.
How do I get the full Form 483 for TAPI Puerto Rico 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.