New England Cryogenic Center, Inc.

FDA Regulatory Profile

New England Cryogenic Center, Inc. has 0 FDA recalls, 13 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 13, 2025 · NAI

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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
Inspections13Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 13, 2025Marlborough, MABiologicsNo Action Indicated (NAI)3002733251
Jul 18, 2023Newton, MABiologicsNo Action Indicated (NAI)3005374514
Nov 3, 2021Marlborough, MABiologicsNo Action Indicated (NAI)3002733251
Mar 7, 2019Newton, MABiologicsNo Action Indicated (NAI)3005374514
Nov 5, 2018Marlborough, MABiologicsNo Action Indicated (NAI)3002733251
Mar 28, 2017Newton, MABiologicsNo Action Indicated (NAI)3005374514
Dec 7, 2016Marlborough, MABiologicsNo Action Indicated (NAI)3002733251
Sep 10, 2014Marlborough, MABiologicsNo Action Indicated (NAI)3002733251
Mar 25, 2014Newton, MABiologicsNo Action Indicated (NAI)3005374514
Feb 13, 2013Marlborough, MABiologicsVoluntary Action Indicated (VAI)3002733251
Mar 6, 2012Marlborough, MABiologicsVoluntary Action Indicated (VAI)3002733251
Mar 16, 2011Marlborough, MABiologicsNo Action Indicated (NAI)3002733251
Feb 14, 2011Marlborough, MABiologicsNo Action Indicated (NAI)3002733251

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 3002733251Marlborough, MA9Aug 13, 2025
FEI 3005374514Newton, MA4Jul 18, 2023

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