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