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Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company FDA Record

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

Latest inspection VAI · Jul 12, 2021
Last warning letter 2010

Inspections 12

2 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Sep 30, 2010

510(k) clearances 0 None on file

Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company has 0 FDA recalls, 12 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company, the most recent on Sep 30, 2010.

What these totals cover: FDA records filed under the name "Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company" and its spelling variant "Bristol-Myers Squibb Holdings Pharma Ltd. Liability".

Latest inspection: Jul 12, 2021 · 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	12	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company: FDA inspections per year

Year	Inspections	OAI
2026	0	0
2025	0	0
2024	0	0
2023	0	0
2022	0	0
2021	1	0
2020	0	0
2019	2	1
2018	0	0
2017	1	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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Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company FDA Warning Letters

1 warning letter on Sep 30, 2010.

Issued	Subject	Issuing office	Close-out letter
Sep 30, 2010 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

12 inspections from Mar 27, 2009 to Jul 12, 2021.

Date	Site	Product	Classification	FEI
Jul 12, 2021	Manati, PR	Devices	Voluntary Action Indicated (VAI)	2650089
Nov 19, 2019	Manati, PR	Drugs	Voluntary Action Indicated (VAI)	2650089
Feb 6, 2019	Manati, PR	Drugs	Official Action Indicated (OAI)	2650089
Sep 11, 2017	Manati, PR	Drugs	Voluntary Action Indicated (VAI)	2650089
May 18, 2016	Manati, PR	Drugs	No Action Indicated (NAI)	2650089
Nov 17, 2015	Manati, PR	Devices	No Action Indicated (NAI)	2650089
May 16, 2014	Manati, PR	Drugs	No Action Indicated (NAI)	2650089
Jan 19, 2012	Manati, PR	Drugs	No Action Indicated (NAI)	2650089
Mar 28, 2011	Manati, PR	Devices	No Action Indicated (NAI)	2650089
Aug 13, 2010	Manati, PR	Drugs	Voluntary Action Indicated (VAI)	2650089
Mar 31, 2010	Manati, PR	Drugs	Official Action Indicated (OAI)	2650089
Mar 27, 2009	Manati, PR	Drugs	Voluntary Action Indicated (VAI)	2650089

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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Sep 30, 2010.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 2650089	Manati, PR	12	Jul 12, 2021

Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company and the FDA: common questions

Has Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company. The most recent is dated Sep 30, 2010.

Has Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company received an FDA Form 483?

FDA has not published a Form 483 for "Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company?

The most recent FDA inspection on file ended Jul 12, 2021 at Manati, PR and was classified VAI. FDA has 12 inspections of Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company on file, 2 of them classified OAI (official action indicated).

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