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ProCaire, Limited Liability Company — FDA Facility Profile

FEI 3014721008

ProCaire, Limited Liability Company is an FDA-registered facility (FEI 3014721008) located in Plainville, MA, US. Registered operations: MANUFACTURE. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
May 17, 2019: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 VAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
May 17, 2019Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Defined areas of adequate size for operations (21 CFR 211.42(c))
Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Computer control of master formula records (21 CFR 211.68(b))
and 2 more

Facility details

Company
ProCaire, LLC
Location
Plainville, MA (US)
Registration Expires
Dec 31, 2026
Operations
MANUFACTURE
Source
decrs

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.