Include any documentation necessary to show that the corrective actions have been achieved. 26, or via email. Your quality unit does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. It is your responsibility to ensure that your establishment fully complies with the law. Inaccuracies like these create the potential for missing the timely detection of microbiological contamination. Fenwal, Inc. develops transfusion medicine and cell therapies. Sincerely, 2. CLAIM THIS BUSINESS. However, your response is inadequate in that it lacks: • Your market action plan if any batches fail to meet the criteria for the statistical verification testing for sterility. The media plate was (b)(4). The media plate was subsequently (b)(4).
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). We have reviewed your written responses, dated October 18, 2019, December 20, 2019, February 20, 2020, and April 24, 2020 to the Form FDA 483. 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 Failure to promptly correct these deviations may result in regulatory action without further notice. For example: a. About MedexSupply.com . At the close of the inspection, FDA issued a Form FDA 483, List of lnspectional Observations, which described a number of significant CGMP deviations from applicable requirements of Section 501 (a)(2)(B) of the Federal Food, Drug and Cosmetic Act (FD&C Act) in the manufacture of your blood-pack unit intermediates. 20-603610. Elizabeth A. Waltrip Fenwal, Inc. 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. Dear Mr. Hauer: The United States Food and Drug Administration (FDA) conducted an inspection of your firm, Fenwal International, Inc., located at Carr … Per SOP MA-03-01-013, entitled "Buenas Practicas De Documentacion", changes to original (b)(4). The .gov means it’s official.Federal government websites often end in .gov or .mil. FDA investigators observed several data discrepancies between recorded microbial plate results and actual observed microbial growth which were verified with the Microbiology Laboratory Manager. We acknowledge the corrective actions you represent that you have taken in response to the observations, your commitment to implement additional corrective actions, and your plan to provide updates. However, your Microbiology Laboratory Manager counted (b)(4) CFUs on the (b)(4).
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Your Microbiology Laboratory Analyst reported (b)(4). Your response lists over 350 complaints with various extensions, dating as far back as July 30, 2018, some remaining open to date. The site is secure. Maricao 00606 With one of the largest catalogs of medical, surgical, and diagnostic supplies available online, Medex Supply can provide your facility with all the medical equipment necessary to … Medical professionals, medical facility employees 855.571.2100. You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations in all your facilities.
Descriptions of these investigations include "leak before use," "particulate matter," "discolored solution," and "mold." Specific violations include, but are not limited to: On September 16, 2019, your Microbiology Laboratory did not accurately document test results. Manufacturer: Fenwal Inc. Create a hermetic seal of the tubing, cost effective, convenient. Login . 800.422.0280. However, bioburden data results for batch FM19I10017 were (b)(4) by your Microbiology Laboratory Analyst (b)(4). FDA investigators found multiple other similar examples of underreporting. Please see FDA's guidance document Data Integrity and Compliance with Drug CGMP for recommendations on establishing and following CGMP compliant data integrity practices at: https://www.fda.gov/downloads/drugs/guidances/ucm495891.pdf. Please be advised that incomplete and inaccurate records call into question the integrity of all your microbiological data. Program Division Director
406, White Plains, NY 10605, or emailed to firstname.lastname@example.org. /S/ Accounts Receivable 800.453.5180 The deviations identified above are not intended to be an all-inclusive list of violations at your facility. We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. We acknowledge your decision to retain third-party oversight of Microbiology Laboratory tests and data documentation and several other remediation measures until full confidence is restored in the Microbiology Laboratory. Call Us. 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. However, your Microbiology Laboratory Manager counted (b)(4) CFUs on the (b)(4).
Carr 357, Km0.8 The deficiencies include, but are not limited to the following: 1. Business Info. Data Integrity Remediation If you cannot complete all corrections within fifteen (15) working days, please explain the reason for your delay and the time frame within which the remaining corrections will be completed.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. You should take prompt action to correct these deviations. For your business. 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).
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