Fenwal International, Inc.
Form 483 issued September 24, 2022 · Maricao, Puerto Rico
- Inspection
- Sep 12 – Sep 24, 2022
- Investigators
- Laura E. Garcia· Scott Ballard
- Observations
- 9
- Pages
- 8
- FEI number
- 2627511
In short: On September 24, 2022, FDA issued a Form 483 with 9 observations to Fenwal International, Inc. in Maricao, Puerto Rico (FEI 2627511) after an inspection that ran Sep 12 – Sep 24, 2022. The investigators were Laura E. Garcia and Scott Ballard. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and laboratory controls account for 6 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
The quality control unit lacks authority to fully investigate…
- 03
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 04
Your firm failed to establish written procedures for production and process controls designed to assure that…
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 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fenwal International, Inc.?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Fenwal International, Inc.?
Laura E. Garcia and Scott Ballard are named on this Form 483, for the inspection of Sep 12 – Sep 24, 2022. Each investigator has a profile showing what they cite most.
When was Fenwal International, Inc. inspected by FDA?
The inspection ran Sep 12 – Sep 24, 2022, and the Form 483 is dated September 24, 2022.
How do I get the full Form 483 for Fenwal International, Inc.?
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