The FDA released a Draft Guidance titled “Nonbinding Feedback After Certain FDA Inspections of Device Establishments”, on February 19, 2019.  It provides a very limited set of conditions where companies can request non-binding FDA feedback to the adequacy of planned corrective actions. The request must be submitted within 15 days of the issuance of the...Read More

Recipient:Guidant CorpProduct: TA-200 Thermal Angel Blood and IV Fluid Infusion Warmer Date:9/22/05 There are no corrective and preventive actions to change design control procedures to identify or prevent memory overflow or similar software programming problems from recurring. Software used as part of production and the quality system has not been fully validated for its intended...Read More

Recipient: Guidant CorpProduct: Insignia Pacemaker Date: 9/22/05 There are no corrective and preventive actions to change design control procedures to identify or prevent memory overflow or similar software programming problems from recurring. Software used as part of production and the quality system has not been fully validated for its intended use according to an established...Read More

483Company: American Red Cross City and Sate: Baltimore, MD FDA District: Baltimore, MD Dates of Inspection: 4/22-6/21/02 4. Failure of the quality control unit to determine root cause and prevent recurrence of significant deviations related to BSD 73.200M, “Shipping” version 1.7 January 2001. Between October 22, 2001 and April 23, 2002, the Chesapeake Region recorded...Read More

Bernafon-MAICO Inc. 5/06/97 “Computer Validation The inspection found that the xxxx Computer System, used to add bulk quantities of solvents to the manufacturing processes (from a tank farm) for Ticlopidine and Bromocryptine Mesylate drug substances has not been validated (FDA-483 Item #16). The response to FDA-483 Item #16 is inadequate. Your firm’s commitment is to...Read More