Fenwal International, Inc.
Form 483 issued September 24, 2021 · Maricao, Puerto Rico
- Inspection
- Sep 8 – Sep 24, 2021
- Investigators
- Annette Melendez· Laura E. Garcia· Randy L. Clarida
- Observations
- 4
- Pages
- 8
- FEI number
- 2627511
In short: On September 24, 2021, FDA issued a Form 483 with 4 observations to Fenwal International, Inc. in Maricao, Puerto Rico (FEI 2627511) after an inspection that ran Sep 8 – Sep 24, 2021. The investigators were Annette Melendez, Laura E. Garcia and Randy L. Clarida. Most observations concern quality system and production.
At a glance
Quality system and production account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written records of investigations into unexplained discrepancies do not always include…
- 02
Complaint records are deficient in that they do not include the findings of…
- 03
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Annette Melendez
2 documents · 2021–2026
Cites 211.110(a) (sampling and testing of in-process materials and drug products) 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 211.192
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 quality system and production. The opening words of each observation are shown on this page.
Who inspected Fenwal International, Inc.?
Annette Melendez, Laura E. Garcia and Randy L. Clarida are named on this Form 483, for the inspection of Sep 8 – Sep 24, 2021. Each investigator has a profile showing what they cite most.
When was Fenwal International, Inc. inspected by FDA?
The inspection ran Sep 8 – Sep 24, 2021, and the Form 483 is dated September 24, 2021.
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.