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Custom Ocular Prosthetics, Seattle, WA – FDA Inspections

Inspection records and compliance data for Custom Ocular Prosthetics in Seattle, Washington. 4 FDA inspections on record, last inspected July 15, 2014.

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Company Profile

This profile covers Custom Ocular Prosthetics based in Seattle, Washington, United States.

FDA Inspection History

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

First inspected July 1, 2009. Last inspected July 15, 2014.

Most cited issue areas

  • Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
  • Lack of procedures, or not maintained1 inspection
  • Management review - Lack of or inadequate procedures1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
July 15, 2014VAIMedical Devices & Rad Health · Compliance: Devices887634
October 4, 2012VAIMedical Devices & Rad Health · Compliance: Devices802528
May 11, 2011NAIMedical Devices & Rad Health · Compliance: Devices724123
July 1, 2009NAIMedical Devices & Rad Health · Compliance: Devices594992
FDA documents

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

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Evergreen Orthopedic Research Lab, LLC
Jayson S. Brower, M.D.
Company Information

Name

Custom Ocular Prosthetics

FEI Number

1000524616

Address

10212 5th Ave NE Ste 210, Seattle, Washington 98125, United States

Country

United States

ID: 0bc481d9-034b-4d7c-8a03-07d99e94604b

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