Inspections, Compliance, Enforcement, and Criminal Investigations
Medrad Inc 5/17/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Avenue
VIA UNITED PARCEL SERVICE
MAY 17 2011
Mr. Sam Liang
President & CEO
100 Global View Drive
Warrendale, Pennsylvania 15086
Dear Mr. Liang:
During an inspection of your firm located in Indianola, Pennsylvania, on January 4, 2011, through February 3, 2011, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Avanta Fluid Management Injection System. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.
Our inspection revealed that your Avanta Fluid Management Injection System devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the devices that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 CFR Part 806 – Reports of Corrections and Removals regulation. Significant violations include, but are not limited to, the following:
Failure to submit a written report to FDA within 10 working days of initiating any correction or removal of a device, in order to reduce a risk to health posed by the device, as required by 21 CFR 806.10(a)(b).
For example, the report of your corrective actions (CAPAR 50001564 Action Update) dated December 28, 2010, indicates that your firm received 45 reports of alleged air injections during procedures in which the Avanta system was in use, between January 1, 2007, and July 24, 2009. As a result of these alleged air injections, Medrad instituted the following corrective actions:
a) Issued an “Important Product Safety Reminder: User diligence in reducing air embolism risks with the Avanta Quick Set Up Guide for MPAT and SPAT purging;”
b) Released an advanced single patient disposable set with a new pressure isolation valve making the priming process simpler to perform; and
c) Upgraded the software and set up procedure in the graphical user display to allow one step priming of both SPDS lines.
There is no evidence that Medrad submitted a report of Correction and Removal in response to the corrections.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps you have taken to correct the noted violations, as well as an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions you have taken. If your planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of these activities. If corrections and/or corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed. Your response should be comprehensive and address all violations included in this WL.
Your response should be sent to: William C. MacFarland, Director, Division of Enforcement B, Office of Compliance, WO66, Room 3680, 10993 New Hampshire Avenue, Silver Spring, Maryland 20993. Please refer to CMS # 180992 when replying. If you have any questions about the content of this letter please contact: Daniel G. Walter at (301) 796-5582 or fax at (301) 847-8138.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Steven D. Silverman
Office of Compliance
Center for Devices and