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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.
Observations: The device history record does not demonstrate that the device was manufactured in accordance with the device master record.
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