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Mesa Laboratories Bozeman Manufacturing Facility (Zoot) — FDA Facility Profile

FEI 3013667284

Mesa Laboratories Bozeman Manufacturing Facility (Zoot) is an FDA-registered facility (FEI 3013667284) located in Bozeman, MT, US. RegDataLab tracks 8 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Sep 23, 2026: No Action Indicated (NAI)
Inspections on record
8 (2 VAI, 6 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
Recalls as the recalling firm
1, latest Feb 12, 2018

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
Sep 23, 2026No Action Indicated (NAI)No citations listed
Jun 14, 2019No Action Indicated (NAI)No citations listed
Dec 7, 2016No Action Indicated (NAI)No citations listed
May 14, 2015No Action Indicated (NAI)No citations listed
Sep 20, 2012No Action Indicated (NAI)No citations listed
May 11, 2012Voluntary Action Indicated (VAI)No citations listed
Jul 13, 2011No Action Indicated (NAI)No citations listed
Aug 5, 2009Voluntary Action Indicated (VAI)DMR production process specifications (21 CFR 820.181(b))
Maintenance schedule, Lack of or inadequate schedule (21 CFR 820.70(g)(1))
Activity documentation (21 CFR 820.70(g)(1))

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Feb 12, 2018Not yet classifiedZ-1273-2018ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471 and 1 more product
The concentration of bromocresol purple in the recalled lots does not conform to specification.

Facility details

Company
Mesa Laboratories, Inc., Bozeman Manufacturing Facility
Location
Bozeman, MT (US)
Source
device

FDA data resources

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