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GREFI

FDA Regulatory Profile

GREFI has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 14, 2021 · OAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections4Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 14, 2021Ponce, PRBiologicsOfficial Action Indicated (OAI)3004841580
Oct 1, 2019Ponce, PRBiologicsOfficial Action Indicated (OAI)3004841580
Apr 5, 2018Ponce, PRBiologicsVoluntary Action Indicated (VAI)3004841580
Aug 31, 2015Ponce, PRBiologicsVoluntary Action Indicated (VAI)3004841580

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3004841580Ponce, PR4Jun 14, 2021

FDA data resources

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