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W.R. Grace & Co.-Conn.

FDA Regulatory Profile

W.R. Grace & Co.-Conn. has 0 FDA recalls, 1 inspection, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Nov 18, 2025 · NAI
Latest 510(k)
Dec 9, 1987

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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) clearances2Nov 8, 2026File dated Nov 2, 2026Current
Inspections1Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Nov 18, 2025Tyrone, PAFood/CosmeticsNo Action Indicated (NAI)3025385538

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 3025385538Tyrone, PA1Nov 18, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K873887MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL.Dec 9, 1987
K860804MEDICAL ADHESIVE TAPEMar 24, 1986

FDA data resources

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