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Berkline, LLC, Morristown, TN, Sept. 21 (New Orleans).

Publication: Warning Letter Bulletin
Publication Date: 01-OCT-06
Format: Online
Delivery: Immediate Online Access
Full Article Title: Berkline, LLC, Morristown, TN, Sept. 21 (New Orleans).(MEDICAL DEVICES)

Article Excerpt
An FDA investigation conducted July 24-31 at the Livingston, TN-location of the manufacturer of automated lift chairs, revealed that Berkline was not in conformance with the current GMP requirements of the QS regulation.

Violations included, but were not limited to, failure to maintain proper management controls to ensure QS...

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