BCM Ltd. FDA Record

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

BCM Ltd. has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "BCM Ltd." is on file.

What these totals cover: FDA records filed under the name "BCM Ltd." and its spelling variants "Bcm", "Bcm Co".

Latest inspection
Sep 18, 2025 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections6Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

BCM Ltd.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

BCM Ltd.: FDA inspections per year 2017: 0 inspections020172018: 0 inspections020182019: 1 inspections120192020: 0 inspections020202021: 0 inspections020212022: 1 inspections120222023: 0 inspections020232024: 1 inspections120242025: 1 inspections120252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202410000
202300000
202210000
202100000
202000000
201910000
201800000
201700000

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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Recent FDA inspections

6 inspections from Oct 11, 2010 to Sep 18, 2025.

DateSiteProductClassificationFEI
Sep 18, 2025Goyang, Korea (The Republic Of)DevicesNo Action Indicated (NAI)3014172183
Oct 25, 2024Auburn, CAFood/CosmeticsNo Action Indicated (NAI)3012129909
Jan 21, 2022Nottingham, United KingdomDrugsVoluntary Action Indicated (VAI)3002806563
Sep 13, 2019Nottingham, United KingdomDrugsNo Action Indicated (NAI)3002806563
Jul 29, 2016Nottingham, United KingdomDrugsVoluntary Action Indicated (VAI)3002806563
Oct 11, 2010Nottingham, United KingdomDrugsVoluntary Action Indicated (VAI)3002806563
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

3 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3014172183Goyang, Korea (The Republic Of)1Sep 18, 2025
FEI 3012129909Auburn, CA1Oct 25, 2024
FEI 3002806563Nottingham, United Kingdom4Jan 21, 2022

BCM Ltd. and the FDA: common questions

Has BCM Ltd. received an FDA warning letter?

No FDA warning letter addressed to the name "BCM Ltd." 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 BCM Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "BCM Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect BCM Ltd.?

The most recent FDA inspection on file ended Sep 18, 2025 at Goyang, Korea (The Republic Of) and was classified NAI. FDA has 6 inspections of BCM Ltd. on file.

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