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Red Star Contract Manufacturing, Inc. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Red Star Contract Manufacturing, Inc. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Red Star Contract Manufacturing, Inc." is on file. FDA has published 1 Form 483 for Red Star Contract Manufacturing, Inc..

What these totals cover: FDA records filed under the name "Red Star Contract Manufacturing, Inc." and its spelling variant "Red Star Contract Manufacturing".

Latest inspection: Mar 13, 2025 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	2	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Red Star Contract Manufacturing, Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	1	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	0	0	0	0	0
2017	0	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Red Star Contract Manufacturing, Inc. Form 483s

1 Form 483 published by FDA.

Date	Document	FEI
Mar 13, 2025 · Document on fda.gov	483	3009631939

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

2 inspections from Mar 12, 2024 to Mar 13, 2025.

Date	Site	Product	Classification	FEI
Mar 13, 2025	Larwill, IN	Biologics	Voluntary Action Indicated (VAI)	3009631939
Mar 12, 2024	Larwill, IN	Devices	Voluntary Action Indicated (VAI)	3009631939

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3009631939	Larwill, IN	2	Mar 13, 2025

Red Star Contract Manufacturing, Inc. and the FDA: common questions

Has Red Star Contract Manufacturing, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Red Star Contract Manufacturing, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Red Star Contract Manufacturing, Inc. received an FDA Form 483?

FDA has published 1 Form 483 for Red Star Contract Manufacturing, Inc. in its reading room, the most recent dated Mar 13, 2025. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Red Star Contract Manufacturing, Inc.?

The most recent FDA inspection on file ended Mar 13, 2025 at Larwill, IN and was classified VAI. FDA has 2 inspections of Red Star Contract Manufacturing, Inc. on file.

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