For your business. Medical professionals, medical facility employees 855.571.2100. Need help with SupplyManager? However, your Microbiology Laboratory Manager counted (b)(4) CFUs on the (b)(4). Manufacturer: Fenwal Inc. FDA investigators found multiple other similar examples of underreporting. Your response should be sent to the following address: U.S. Food and Drug Administration, Helen Ricalde, 222 Bloomingdale Rd., Rm. 2. The deviations identified above are not intended to be an all-inclusive list of violations at your facility. Ordering Information; Specifications; … 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. The media plate was subsequently (b)(4). Include any documentation necessary to show that the corrective actions have been achieved.
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.
You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations in all your facilities. The Company offers automated component collection products, storage devices, blood and plasma center products, and ancillary … Failure to promptly correct these deviations may result in regulatory action without further notice. Business Info. Maricao 00606 To view pricing and availability. Inaccuracies like these create the potential for missing the timely detection of microbiological contamination. 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 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). The media plate was (b)(4).
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. Create a hermetic seal of the tubing, cost effective, convenient. 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.
WARNING LETTER. Data Integrity Remediation Your response lists over 350 complaints with various extensions, dating as far back as July 30, 2018, some remaining open to date. 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 … Founded --Incorporated ; Annual Revenue --Employee Count 950; … Specific violations include, but are not limited to: On September 16, 2019, your Microbiology Laboratory did not accurately document test results. Your Microbiology Laboratory Analyst reported (b)(4). 406, White Plains, NY 10605, or emailed to firstname.lastname@example.org. Carr 357, Km0.8 Fenwal, Inc. Per SOP MA-03-01-013, entitled "Buenas Practicas De Documentacion", changes to original (b)(4). Form FDA 483 Observation 5 The site is secure. Sincerely, However, your Microbiology Laboratory Manager counted (b)(4) CFUs on the (b)(4). If you should have any questions, please contact Helen Ricalde, Compliance Officer, at (914) 682-2826 Ext. Your written response acknowledges the significance of your microbial growth count discrepancies; however, at this time it is unknown how long these practices of underreporting, or failure to report, took place, and how widespread these practices were. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The United States Food and Drug Administration (FDA) conducted an inspection of your firm, Fenwal International, Inc., located at Carr 357, Km 0.8, Maricao, PR, between September 16, 2019 and September 26, 2019. 800.422.0280. You should take prompt action to correct these deviations. 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. Your Microbiology Laboratory Analyst failed to document the CFU Total Count value for (b)(4). /S/ The .gov means it’s official.Federal government websites often end in .gov or .mil. CLAIM THIS BUSINESS. KM 0 8 RR 357 MARICAO, PR 00606 Get Directions (787) 838-3000. www.fenwalinc.com . 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. Elizabeth A. Waltrip About MedexSupply.com . 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. Puerto Rico. • 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. b. However, bioburden data results for batch FM19I10017 were (b)(4) by your Microbiology Laboratory Analyst (b)(4). It is your responsibility to ensure that your establishment fully complies with the law. FDA investigators observed several data discrepancies between recorded microbial plate results and actual observed microbial growth which were verified with the Microbiology Laboratory Manager.
Accounts Receivable 800.453.5180
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).
Please be advised that incomplete and inaccurate records call into question the integrity of all your microbiological data. Login . 26, or via email. Fenwal, Inc. develops transfusion medicine and cell therapies. Dear Mr. Hauer: The United States Food and Drug Administration (FDA) conducted an inspection of your firm, Fenwal International, Inc., located at Carr … 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 Call Us. Please provide a timeframe for completing these investigations. 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.
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