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Bimeda-MTC Animal Health FDA Inspection Record

FEI 3001603179 · Inspections, Form 483s, warning letters and import refusals

Bimeda-MTC Animal Health is an FDA-registered facility (FEI 3001603179) located in Cambridge, CA. Registered operations: MANUFACTURE. RegDataLab tracks 7 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Sep 22, 2023: Voluntary Action Indicated (VAI)
Inspections on record
7 (1 OAI, 6 VAI)
Last OAI inspection
Nov 21, 2014
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
2, latest Aug 14, 2014
Import refusals
5

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 22, 2023Voluntary Action Indicated (VAI)No citations listed
Aug 17, 2018Voluntary Action Indicated (VAI)Equipment Design, Size and Location (21 CFR 211.63)
Environmental Monitoring System (21 CFR 211.42(c)(10)(iv))
Cleaning System (21 CFR 211.42(c)(10)(v))
Jul 27, 2017Voluntary Action Indicated (VAI)No citations listed
Aug 4, 2015Voluntary Action Indicated (VAI)No citations listed
Nov 21, 2014Official Action Indicated (OAI)Calibration/Inspection/Checking not done (21 CFR 211.68(a))
SOPs not followed / documented (21 CFR 211.100(b))
Environmental Monitoring System (21 CFR 211.42(c)(10)(iv))
Cleaning System (21 CFR 211.42(c)(10)(v))
and 3 more
Jun 20, 2013Voluntary Action Indicated (VAI)No citations listed
May 5, 2010Voluntary Action Indicated (VAI)No citations listed

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
Aug 14, 2014Class IIV-166-2014Ivermax (Ivermectin) 1% sterile solution is provided in a 500 mL plastic bottle suitable…
This recall has been initiated due to incorrect information printed on the bottle carton. Specifically the carton indicates that the…
Jan 7, 2013Class IIV-192-2013Hypertonic Saline Solution 7.2%; Sterile - Preservative Free; For Animal Use Only… and 2 more products
The sterility of the recalled products cannot be assured.

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
Bimeda MTC Animal Health Inc.
Location
Cambridge (CA)
Registration Expires
Dec 31, 2027
Operations
MANUFACTURE
Source
decrs

Import refusals

FDA data resources

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