Bristol-Myers Squibb Manufacturing Company Unlimited Company, Humacao, PR – FDA Inspections

Inspection records and compliance data for Bristol-Myers Squibb Manufacturing Company Unlimited Company in Humacao, Puerto Rico. 8 FDA inspections on record, 2 Form 483s, last inspected February 14, 2020.

Company Profile

This profile covers Bristol-Myers Squibb Manufacturing Company Unlimited Company based in Humacao, Puerto Rico, United States.

FDA Inspection History

FDA inspections: 8
OAI: 0
VAI: 4
NAI: 4
Form 483s: 2
Warning letters: 0

First inspected June 25, 2010. Last inspected February 14, 2020.

Most cited issue areas

Prepared for each batch, include complete information2 inspections
Complaint Handling Procedure1 inspection
GMP Training Frequency1 inspection

FDA inspections (8)

Date	Result	FDA center(s)	Insp. #
February 14, 2020	NAI	Human Drugs · Drug Quality Assurance	1121802
April 27, 2018	VAI	Human Drugs · Drug Quality Assurance	1051117
November 18, 2016	VAI	Human Drugs · Drug Quality Assurance	993014
December 9, 2015	NAI	Human Drugs · Drug Quality Assurance	956226
February 20, 2014	VAI	Human Drugs · Drug Quality Assurance	866747
February 2, 2012	NAI	Human Drugs · Drug Quality Assurance	768189
March 9, 2011	NAI	Human Drugs · Drug Quality Assurance	717352
June 25, 2010	VAI	Human Drugs · Drug Quality Assurance	669021

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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