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Bi-Coastal Pharma International

FDA Regulatory Profile

Bi-Coastal Pharma International has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
Jan 14, 2022 · 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
Inspections2Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jan 14, 2022Shrewsbury, NJDrugsOfficial Action Indicated (OAI)3013263547
Sep 14, 2020Shrewsbury, NJDrugsVoluntary Action Indicated (VAI)3013263547

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 3013263547Shrewsbury, NJ2Jan 14, 2022

FDA data resources

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