483s Alerts

Full Issue

June 25, 2014

Dear Subscriber,

The following 483s recently have been added to 483sOnline.com. To access all available 483s, visit us at http://www.fdanews.com/form483.

CBI Laboratories, Inc.
Issued: 02/14/2014 Region: Southwest Inspector(s): Lisa Jennings
Observations: There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

IBA Molecular North America, Inc.
Issued: 02/14/2014 Region: Pacific Inspector(s): Daniel J. Roberts; Eileen A. Liu
Observations: You did not oversee production operations in a manner to ensure that each PET drug meets the quality and purity characteristics that it is supposed to have.

Laureate Biopharmaceuticals Services, Inc.
Issued: 09/26/2013 Region: Central Inspector(s): Barbara J. Wilimczyk-Macri
Observations: The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

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Asante Solutions, Inc.
Issued: 04/10/2014 Region: Pacific Inspector(s): Joseph A. Seitz
Observations: Complaint files are not maintained.

Airways Development LLC
Issued: 04/09/2014 Region: Central Inspector(s): David H. Smith
Observation: Quality audits have not been performed.

Mycone Dental Supply Co., Inc., dba Keystone Industries
Issued: 04/03/2014 Region: Central Inspector(s): Loretta Nemchik
Observations: The device history record does not demonstrate that the device was manufactured in accordance with the device master record.

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