Ortho Biologics, LLC, Manati, PR – FDA Inspections

Inspection records and compliance data for Ortho Biologics, LLC in Manati, Puerto Rico. 15 FDA inspections on record, last inspected January 24, 2020.

Company Profile

This profile covers Ortho Biologics, LLC based in Manati, Puerto Rico, United States.

FDA Inspection History

FDA inspections: 15
OAI: 0
VAI: 10
NAI: 5
Form 483s: 0
Warning letters: 0

First inspected May 4, 2009. Last inspected January 24, 2020.

Most cited issue areas

Investigations of discrepancies, failures2 inspections
Cleaning SOPs/schedules1 inspection
Failure to meet specifications1 inspection

FDA inspections (15)

Date	Result	FDA center(s)	Insp. #
January 24, 2020	NAI	Human Drugs · Drug Quality Assurance	1118152
April 25, 2019	NAI	Human Drugs · Drug Quality Assurance	1089445
July 20, 2017	NAI	Human Drugs · Drug Quality Assurance	1022029
May 12, 2017	NAI	Human Drugs · Drug Quality Assurance	1015645
February 11, 2016	VAI	Human Drugs · Drug Quality Assurance	963080
January 16, 2015	VAI	Human Drugs · Drug Quality Assurance	910099
July 3, 2014	NAI	Human Drugs · Drug Quality Assurance	889194
May 23, 2014	VAI	Human Drugs · Drug Quality Assurance	881607
February 14, 2013	VAI	Human Drugs · Drug Quality Assurance	818595
June 29, 2012	VAI	Human Drugs · Drug Quality Assurance	789030
April 20, 2011	VAI	Human Drugs · Drug Quality Assurance	721627
June 28, 2010	VAI	Human Drugs · Drug Quality Assurance	669409
June 25, 2010	VAI	Human Drugs · Drug Quality Assurance	669552
May 11, 2009	VAI	Human Drugs · Drug Quality Assurance	584926
May 4, 2009	VAI	Human Drugs · Drug Quality Assurance	582451

FDA documents

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

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