483sOnline.com - One-Year Unlimited Access Subscription FDAnews Form 483s Sample List Bio-Pharm, Inc. Issued: 11/21/12 Region: Central Category: Drug 483s Inspector(s): Anita R. Michael Observations: Buildings used in the manufacturing, processing and packing of a drug product are not maintained in a good state of repair. Neurovision Medical Products, Inc. Issued: 11/20/12 Region: Pacific Category: Device 483s Inspector(s): Sarah A. Hassass Observations: Procedures for rework of nonconforming product have not been adequately established. Cardinal Health 414, LLC Issued: 11/19/12 Region: Southwest Category: Drug 483s Inspector(s): Erika V. Butler Observations: You did not notify all facilities that received a PET drug product that failed to meet a criterion for sterility of the findings from your investigation. Stryker Instruments Div. of Stryker Corp. Issued: 11/9/12 Region: Central Category: Device 483s Inspector(s): Benjamin J. Dastoli, Allison M. Scheck Observations: A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA. Fredrikson Verkstad AB Issued: 10/12/12 Region: HQ Category: Device 483s Inspector(s): Thai Duong Observations: Procedures for device history records have not been adequately established. AllerQuest, LLC Issued: 5/18/12 Region: Northeast Category: Drug 483s Inspector(s): Ramon E. Martinez, Robert J. Martin, Allison A. Aldridge 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. Subscribe Today! Get access to these form 483s! It’s simple. Sign up for your annual subscription to the 483sOnline.com database today and gain immediate access to valuable 483s without waiting the hassle of filing a FOIA request and waiting for the form to be sent to you. This subscription is for single user only. Licenses for multiple users and/or multiple locations are also available at significant discounts. For more information, contact Nelly Valentin at [email protected] or (888) 838-5578.
© Copyright 2020