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RED STAR CONTRACT MANUFACTURING INC. FDA Inspection Record

FEI 3009631939 · Inspections, Form 483s, warning letters and import refusals

RED STAR CONTRACT MANUFACTURING INC. is an FDA-registered facility (FEI 3009631939) located in Larwill, IN, US. RegDataLab tracks 2 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 13, 2025: Voluntary Action Indicated (VAI)
Inspections on record
2 (2 VAI)
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
Form 483 and inspection documents
1 in FDA's reading room

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 13, 2025Voluntary Action Indicated (VAI)Contamination, mix ups, improper release (21 CFR 1271.260(a))
Periodic review of temperatures (21 CFR 1271.260(e))
Mar 12, 2024Voluntary Action Indicated (VAI)Lack/Inad procedure-Monitoring/Control of Validated Proces (21 CFR 820.75(b))
Lack of or inadequate receiving acceptance procedures (21 CFR 820.80(b))
Lack of or inadequate procedures (21 CFR 820.100(a))
DHR content (21 CFR 820.184)
and 3 more

Form 483s and inspection documents

  • 483 on FDA.gov
    FDA listing date Mar 13, 2025, which is not always the inspection or issue date. Published by FDA Oct 26, 2026.

FDA record score

10 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 14, 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.

2 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIMar 13, 20256 x 16
Inspection classified VAIMar 12, 20246 x 0.63.6

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 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 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Red Star Contract Manufacturing, Inc.
Location
Larwill, IN (US)
Source
device

FDA data resources

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