FDA Inspection 820861 - Automated Ophthalmics, Inc. - March 05, 2013

FDA Inspection 820861 for Automated Ophthalmics, Inc. on March 05, 2013. Classification: Official Action Indicated (OAI).

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Record Summary

FDA Inspection 820861 for Automated Ophthalmics, Inc. on March 05, 2013. Classification: Official Action Indicated (OAI).

Violation Codes

21 CFR 803.17

21 CFR 820.184

21 CFR 820.20(c)

21 CFR 820.22

21 CFR 820.250(b)

21 CFR 820.30(a)

21 CFR 820.30(j)

21 CFR 820.50(a)(1)

21 CFR 820.75(a)

21 CFR 820.80(e)

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Record Information

Company

Automated Ophthalmics, Inc.

Inspection Date

March 5, 2013

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: f96e9f4a-87b9-4660-afd6-bc3b34ce633b

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