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Purisys LLC — FDA Facility Profile

FEI 3012286613

Purisys LLC is an FDA-registered facility (FEI 3012286613) located in Athens, GA, US. Registered operations: API MANUFACTURE. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Mar 13, 2024: Voluntary Action Indicated (VAI)
Inspections on record
2 (1 VAI, 1 NAI)
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
Mar 13, 2024Voluntary Action Indicated (VAI)Procedures To Be in Writing (21 CFR 211.80(a))
Sanitation--buildings not clean, free of infestation (21 CFR 211.56(a))
Jun 15, 2017No Action Indicated (NAI)No citations listed

Facility details

Company
Purisys LLC
Location
Athens, GA (US)
Registration Expires
Dec 31, 2027
Operations
API MANUFACTURE
Source
decrs

FDA data resources

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