Tapi Puerto Rico, Inc.
Form 483 issued November 17, 2014 · Humacao, Puerto Rico
- Inspection
- Nov 5 – Nov 17, 2014
- Investigator
- Jose E. Melendez
- Observations
- 4
- Pages
- 2
- FEI number
- 1000350351
In short: On November 17, 2014, FDA issued a Form 483 with 4 observations to Tapi Puerto Rico, Inc. in Humacao, Puerto Rico (FEI 1000350351) after an inspection that ran Nov 5 – Nov 17, 2014. The investigator was Jose E. Melendez. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The batch prod jetion record corresponding to 5-Fluorouracil drug substance is deficient in that it does…
- 02
Reserve sample :s from representative sample lots or batches of finished drug substance are not examined…
- 03
Your samplingjplan for final QC-testing of 5-Fluorouracil drug substance is inadequate in that it fails to…
- 04
Your firm failejd to maintain and to consistently inspect critical systems in the conditions needed to…
This inspection in context
Jose E. Melendez
44 documents · 2001–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmTapi Puerto Rico, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tapi Puerto Rico, Inc.?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Tapi Puerto Rico, Inc.?
Jose E. Melendez is named on this Form 483, for the inspection of Nov 5 – Nov 17, 2014. Each investigator has a profile showing what they cite most.
When was Tapi Puerto Rico, Inc. inspected by FDA?
The inspection ran Nov 5 – Nov 17, 2014, and the Form 483 is dated November 17, 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.