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Company
•United States

Rocky Mountain Lions Eye Bank, Aurora, CO – FDA Inspections

Inspection records and compliance data for Rocky Mountain Lions Eye Bank in Aurora, Colorado. 6 FDA inspections on record, 1 Form 483, last inspected September 27, 2024.

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Company Profile

This profile covers Rocky Mountain Lions Eye Bank based in Aurora, Colorado, United States.

FDA Inspection History

FDA inspections
6
OAI
0
VAI
4
NAI
2
Form 483s
1
Warning letters
0

First inspected February 3, 2009. Last inspected September 27, 2024.

Most cited issue areas

  • Procedures to meet core CTGP2 inspections
  • Design of procedures to ensure compliance1 inspection
  • Deviations not reported to FDA1 inspection

FDA inspections (6)

DateResultFDA center(s)Insp. #
September 27, 2024VAIBiologics · Blood and Blood Products1250468
April 26, 2018NAIBiologics · Blood and Blood Products1057040
August 21, 2015VAIBiologics · Human Cellular, Tissue, and Gene Therapies951842
February 16, 2012VAIBiologics · Human Cellular, Tissue, and Gene Therapies769336
August 12, 2010NAIBiologics · Human Cellular, Tissue, and Gene Therapies676302
February 3, 2009VAIBiologics · Human Cellular, Tissue, and Gene Therapies563285
FDA documents

Form 483s (1)

  • Form 483s · September 27, 2024

EIRs (3)

  • EIRs · September 27, 2024
  • EIRs · April 26, 2018
  • EIRs · August 21, 2015
People (4)
Marc A. Jackson
Person
Carla R. Hinz
Person
Kelly D. Moore
Person
Shelley H. Beausoleil
Person
Related Companies (10)

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Biomat USA, Inc.
Octapharma Plasma Inc
BioLife Plasma Services L.P.
Talecris Plasma Resources (Biomat USA, Inc.)
Clinical Laboratories of Hawaii Inc
Olgam Life LLC
Company Information

Name

Rocky Mountain Lions Eye Bank

FEI Number

1000517466

Address

1675 Aurora Ct # Ei2049, Aurora, Colorado 80045, United States

Country

United States

ID: a70245a1-55c2-4c8f-b151-b578bb1c331d

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