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CMIC CMO USA CORPORATION FDA Inspection Record

FEI 3001237056 · Inspections, Form 483s, warning letters and import refusals

CMIC CMO USA CORPORATION is an FDA-registered facility (FEI 3001237056) located in Cranbury, NJ, US. Registered operations: ANALYSIS; MANUFACTURE; PACK. RegDataLab tracks 7 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 31, 2023: No Action Indicated (NAI)
Inspections on record
7 (4 VAI, 3 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 31, 2023No Action Indicated (NAI)No citations listed
May 4, 2021No Action Indicated (NAI)No citations listed
Jan 11, 2018Voluntary Action Indicated (VAI)Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Absence of Written Procedures (21 CFR 211.100(a))
Following/documenting laboratory controls (21 CFR 211.160(a))
Complete Test Data (21 CFR 211.194(a)(4))
and 1 more
Feb 13, 2015Voluntary Action Indicated (VAI)No citations listed
Dec 4, 2013Voluntary Action Indicated (VAI)Investigations of discrepancies, failures (21 CFR 211.192)
Nov 30, 2011Voluntary Action Indicated (VAI)Control procedures to monitor and validate performance (21 CFR 211.110(a))
Complete instructions, procedures, specifications et. al. (21 CFR 211.186(b)(9))
Apr 8, 2010No Action Indicated (NAI)No citations listed

FDA record score

2 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

4 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIJan 11, 20186 x 0.251.5
Inspection classified VAIFeb 13, 201510 years or older, so it adds no points0
Inspection classified VAIDec 4, 201310 years or older, so it adds no points0
Inspection classified VAINov 30, 201110 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

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Facility details

Company
CMIC CMO USA Corporation
Location
Cranbury, NJ (US)
Registration Expires
Dec 31, 2027
Operations
ANALYSIS; MANUFACTURE; PACK
Source
decrs

FDA data resources

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