However, we have concerns regarding the adequacy of your corrective actions to date including, but not limited to the following: Form FDA 483 Observation 1 The deviations identified above are not intended to be an all-inclusive list of violations at your facility. Descriptions of these investigations include "leak before use," "particulate matter," "discolored solution," and "mold." Please be advised that incomplete and inaccurate records call into question the integrity of all your microbiological data. The deviations are an indication that your quality control unit is not fulfilling its responsibility to assure the identity, strength, quality, and purity of your drug product(s). Data Integrity Remediation Accounts Receivable 800.453.5180 The site is secure. • An update regarding investigation 593423 (b)(4) of your October 2019 response) pertaining to (b)(4) End of Batch that exceeded the Total Count alert limit, as this was not provided for review. Your response should be sent to the following address: U.S. Food and Drug Administration, Helen Ricalde, 222 Bloomingdale Rd., Rm. 406, White Plains, NY 10605, or emailed to helen.ricalde@fda.hhs.gov. To view pricing and availability. Medical professionals, medical facility employees 855.571.2100, Need help with SupplyManager?800.422.0280, McKesson Medical-Surgical Conference Schedule, Formula A Citrate Dextrose Solution Flexible Bag 500 mL, Citrate Dextrose Solution Intravenous Solution Flexible Bag 1000 mL, Sodium Citrate Solution Intravenous Solution Flexible Bag 500 mL, Processing Solution Sodium Chloride 12% Solution Flexible Bag 150 mL, Wash Solution Sodium Chloride 1.6% Solution Flexible Bag 1,000 mL, Processing Solution Dextrose / Sodium Chloride 0.2% - 0.9% Solution Flexible Bag 1,000 mL, Citric Acid / Sodium Citrate Solution 250 mL, Consumers: Please visit SimplyMedical.com. During the inspection, FDA investigators documented deviations from current good manufacturing practice (CGMP) requirements in the manufacture of your blood-pack units (BPUs) with and without in-line leukoreduction filters, as well as lnterSol, a Platelet Additive Solution (PAS). Per SOP MA-03-01-013, entitled "Buenas Practicas De Documentacion", changes to original (b)(4). However, your Microbiology Laboratory Manager counted (b)(4) CFUs on the (b)(4). Office of Biological Products Operations - Division I, President of Transfusion and Cells Technologies Division, An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Inspections, Compliance, Enforcement, and Criminal Investigations, Fenwal International, Inc. - 603610 - 06/14/2020. May 14, 2020. Ordering Information; Specifications; … The media plate was (b)(4). KM 0 8 RR 357 MARICAO, PR 00606 Get Directions (787) 838-3000. www.fenwalinc.com . Form FDA 483 Observation 5 Program Division Director
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