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Company
•United States

Infinity Laboratories LLC, Castle Rock, CO – FDA Inspections

Inspection records and compliance data for Infinity Laboratories LLC in Castle Rock, Colorado. 3 FDA inspections on record, last inspected January 07, 2021.

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Company Profile

This profile covers Infinity Laboratories LLC based in Castle Rock, Colorado, United States.

FDA Inspection History

FDA inspections
3
OAI
0
VAI
3
NAI
0
Form 483s
0
Warning letters
0

First inspected January 7, 2011. Last inspected January 7, 2021.

Most cited issue areas

  • Complete test data included in records2 inspections
  • Acceptance of in-process materials1 inspection
  • Calibration - at intervals, written program, remedial action1 inspection

FDA inspections (3)

DateResultFDA center(s)Insp. #
January 7, 2021VAIHuman Drugs · Drug Quality Assurance1134475
October 29, 2015VAIHuman Drugs · Drug Quality Assurance967245
January 7, 2011VAIHuman Drugs, Medical Devices & Rad Health · Drug Quality Assurance705734
FDA documents

Form 483s (1)

  • Form 483s · January 7, 2021

EIRs (2)

  • EIRs · January 7, 2021
  • EIRs · October 29, 2015
People (3)
Marie Buen-Bigornia
Person
Jai P. Singh
Person
Michael A. Charles
Person
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Company Information

Name

Infinity Laboratories LLC

FEI Number

1000517789

Address

1585 S Perry St Ste B, Castle Rock, Colorado 80104, United States

Country

United States

ID: bad45a66-b869-4687-926a-0a1ca82ac275

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