Fenwal International, Inc.
Form 483 issued August 22, 2017 · Maricao, Puerto Rico
- Inspection
- Aug 1 – Aug 22, 2017
- Investigator
- Laurimer Kuilan-Torres
- Observations
- 4
- Pages
- 6
- FEI number
- 2627511
In short: On August 22, 2017, FDA issued a Form 483 with 4 observations to Fenwal International, Inc. in Maricao, Puerto Rico (FEI 2627511) after an inspection that ran Aug 1 – Aug 22, 2017. The investigator was Laurimer Kuilan-Torres. Most observations concern production and quality system.
At a glance
Observations span 3 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
- 04
Buildings used in the manufacture, processing, packing or holding of drug products are not free of…
This inspection in context
Laurimer Kuilan-Torres
16 documents · 2015–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmFenwal International, Inc. history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fenwal International, Inc.?
FDA listed 4 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Fenwal International, Inc.?
Laurimer Kuilan-Torres is named on this Form 483, for the inspection of Aug 1 – Aug 22, 2017. Each investigator has a profile showing what they cite most.
When was Fenwal International, Inc. inspected by FDA?
The inspection ran Aug 1 – Aug 22, 2017, and the Form 483 is dated August 22, 2017.
How do I get the full Form 483 for Fenwal International, 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.