Fenwal International, Inc.
Form 483 issued September 26, 2019 · Maricao, Puerto Rico
- Inspection
- Sep 16 – Sep 26, 2019
- Investigators
- Laura E. Garcia· Nimmy Mathews
- Observations
- 6
- Pages
- 9
- FEI number
- 2627511
In short: On September 26, 2019, FDA issued a Form 483 with 6 observations to Fenwal International, Inc. in Maricao, Puerto Rico (FEI 2627511) after an inspection that ran Sep 16 – Sep 26, 2019. The investigators were Laura E. Garcia and Nimmy Mathews. Most observations concern production and laboratory controls.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 02
Each lot of a component liable to objectionable microbiological contamination is deficiently subjected to…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Laura E. Garcia
3 documents · 2019–2022
Cites 211.113(b) (control of microbiological contamination) 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 211.194(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fenwal International, Inc.?
FDA listed 6 observations on this Form 483, mostly about production, laboratory controls and materials. The opening words of each observation are shown on this page.
Who inspected Fenwal International, Inc.?
Laura E. Garcia and Nimmy Mathews are named on this Form 483, for the inspection of Sep 16 – Sep 26, 2019. Each investigator has a profile showing what they cite most.
When was Fenwal International, Inc. inspected by FDA?
The inspection ran Sep 16 – Sep 26, 2019, and the Form 483 is dated September 26, 2019.
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.