Fenwal International, Inc.
Form 483 issued March 25, 2015 · Maricao, Puerto Rico
- Inspection
- Mar 18 – Mar 25, 2015
- Investigators
- Cassandra L. Abellard· Jose A. Cruz-Gonzalez
- Observations
- 3
- Pages
- 3
- FEI number
- 2627511
In short: On March 25, 2015, FDA issued a Form 483 with 3 observations to Fenwal International, Inc. in Maricao, Puerto Rico (FEI 2627511) after an inspection that ran Mar 18 – Mar 25, 2015. The investigators were Cassandra L. Abellard and Jose A. Cruz-Gonzalez. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Reserve drug product samples are not retained and stored under conditions…
- 02
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
- 03
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Cassandra L. Abellard
6 documents · 2015–2023
Cites 211.194 (laboratory records) 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 211.170(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fenwal International, Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Fenwal International, Inc.?
Cassandra L. Abellard and Jose A. Cruz-Gonzalez are named on this Form 483, for the inspection of Mar 18 – Mar 25, 2015. Each investigator has a profile showing what they cite most.
When was Fenwal International, Inc. inspected by FDA?
The inspection ran Mar 18 – Mar 25, 2015, and the Form 483 is dated March 25, 2015.
How do I get the full Form 483 for Fenwal International, Inc.?
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