FDA Inspection 683197 - Ocular Systems, Inc. - September 29, 2010

FDA Inspection 683197 for Ocular Systems, Inc. on September 29, 2010. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 683197 for Ocular Systems, Inc. on September 29, 2010. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 1271.160(b)(5)

21 CFR 1271.160(d)

21 CFR 1271.170(b)

21 CFR 1271.195(a)

21 CFR 1271.195(a)(3)

21 CFR 1271.225

21 CFR 1271.230(a)

21 CFR 1271.265(d)

21 CFR 1271.265(e)

21 CFR 1271.55(b)(3)

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Record Information

Company

Ocular Systems, Inc.

Inspection Date

September 29, 2010

Product Type

Biologics

Office

Center for Biologics Evaluation and Research

ID: fcf1a3e4-2b2d-44a3-bbb4-dce4d3aa47aa

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