Inspections, Compliance, Enforcement, and Criminal Investigations
SenoRx, Inc. 19-Jul-05
Department of Health and Human Services
Public Health Service
Los Angeles District
RETURN RECEIPT REQUESTED
July 19, 2005
Mr. Lloyd H. Malchow, President
11 Columbia, Suite A
Aliso Viejo, CA 92656
Dear Mr. Malchow:
An inspection of your firm conducted on April 4-8 and 13, 14, 20, 2005 revealed your firm is a manufacturer of Class II electrosurgical biopsy devices. These products are devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(h)]. The above-stated inspection revealed that this device is adulterated under section 501(h) of the Act [21 U.S.C. 351(h)], in that the methods used in, or the facilities or controls used for its manufacturing, packaging, storage, or installation are not in conformance with the current Good Manufacturing Practice (cGMP) requirements for medical devices which are set forth in the Quality System regulation, as specified in Title 21, Code of Federal Regulation (CFR), Part 820.
Significant deviations include, but are not limited to, the following:
1. Corrective and preventive actions (CAPA) have not been verified or validated to ensure that the action is effective and does not adversely affect the finished device as required by 21 CFR 820.100 (a)(4). For example:
a. Corrective Action Report (CAR) 01-005, for the "Tip Shear" was closed on 6118104. The firm continued to receive complaints regarding the tip of the Gel Mark Ultra Biopsy Site Marker shearing off in the patient's breast during surgery, (Tip Shear). The CAR 01-005 did not eliminate the problem of tip shear. Your firm reported at least 38 complaints and 33 MDRs for tip shear since July 2003. You also did not perform validation or verification of the implemented corrective actions as required in your SOP 14-001.
b. CAR-04-004 was generated to change the pellet deployment force to greater than the maximum specification allowed. The established specification was changed without validation or verification of the new deployment force.
c. Your CAPA SOP 14-001/B, dated 9/11/01 and CAPA SOP 14-001/C, dated 11/16/04 requires CARs to be tracked and closed pursuant to your complaint procedure SOP14-003/F, dated 11/7/04. Your firm's complaint procedure does not specify when to close a CAR nor the requirements for tracking and trending the effectiveness of specified CARs.
2. Complaints (e.g. C03-0171, C03-0178, C03-0185B, C04-0040A) were not evaluated or investigated to determine the potential adverse impacts to the patient from tip shear as required by 21 CFR 820.198 (a)(3). For example, your firm is not following up with physicians to determine the incidence of secondary surgical intervention as a result of the tip remaining in the patient's breast. In addition, CAR 04-007 was opened on 12/22/04 for complaints received on 11/24/2004 regarding granuloma formation following biopsies. The CAR does not address the relationship of these events to prior device failures such as tip shear incidences in these patients.
We acknowledge receipt of your response to the FDA 483, dated May 17, 2005. However, your response is inadequate to address observations 2, 3, and 4 in that your firm has not thoroughly investigated complaints related to the tip of the device shearing off in the patient's breasts during surgery. Your letter indicates that Corrective Actions Report (CAR) 005 was left open to address this issue. However, as noted in 1.a. above, the CAR collected indicates the investigation was closed on 6/18/04 and addressed two separate device failure issues in the same CAR - Failure of Pellets to Deploy and Tip Shear. The investigation primarily focused on the realignment of the applicator to prevent the pellets from jamming during deployment. Due to a lesser number of complaints received the CAR was closed.
Your firm is continuing to receive complaints of tip shear in the breast and no follow-up is being conducted to determine the incidence of secondary surgical intervention as a result of the device shearing off in the breast. You have also not conducted any studies for the biocompatibility of [redacted] resin in the breast over time and the long term effects in the body.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by the Food and Drug Administration (FDA).
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. Also, no requests for Certificates for Products for Export will be approved until the violations relating to the subject devices have been corrected. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action being initiated by FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties.
Please notify this office in writing within 15 days of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to identify and make correction to any underlying systems problems necessary to assure that similar violations will not recur. Please include any and all documentation to show that adequate correction has been achieved. In the case of future corrections, an estimated date of completion, and documentation showing plans for correction should be included with your response to this letter. If you have any questions regarding this letter, please contact Ms. Greco at 949-608-2959.
Please forward your written response to:
Director of Compliance
Los Angeles District
Los Angeles District