| Public Health Service Food and Drug Administration |
| San Francisco District 1431 Harbor Bay Parkway Alameda. CA 94502-7070 Telephone: 510/337-6700 |
Department of Health and Human ServicesWARNING LETTER
VIA United Parcel Service
August 10, 2010
Sharad. H. Joshi
President and COO
Starion Instruments Corp.
775 Palomar Avenue
Sunnyvale, California 94085
Dear Mr. Joshi:
During an inspection of your firm located in Sunnyvale, California on February 8, 2010 through February 25,2010, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures thermal cutting, cautery, and vessel sealing devices such as the TLS 3, Thermal Ligating Shears and TLS 4, RealHand Thermal Seal device. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
This inspection revealed that these devices are adulterated within the meaning of 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, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from Sharad H. Joshi, President and COO, dated March 31, 2010, concerning our investigators' observations noted on the Form FDA 483, Inspectional Observations, that was issued to you. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a).
Specifically, although product quality problems were identified and corrections were made associated with Correction Removal numbers 9 and 10, the corrective action reports were not generated for these corrections and associated activities as specified by SOP 1401 Revision B.
We have reviewed your response dated March 31, 2010, and have concluded that the adequacy of the response cannot be determined at this time. Your firm states that SOP 1401 Rev B will be revised, employees retrained, etc., but the firm did not provide copies of the revised procedure and did not provide evidence that employees had received training on the revised procedure because the promised corrective actions had not occurred at the time of the firm's response.
2. Failure to establish and maintain the complaint handling procedures for receiving, reviewing, and evaluating complaints, as required by 21 CFR 820.198(a).
For example: Although the firms procedure "Comment/Complaint Handing" SOP 1403 Revision F, refers to the Scrub report, FRM0052, in Section 4.1 of the procedure, there are no further instructions in this complaint handling procedure or other standard operating procedures to describe this form and its use. According to the General Manager, the Scrub Reports are used to (b)(4) but these reports may also identify product complaints. Out of twelve Scrub Reports reviewed, report SCR 0961 was the input for complaint PCR 09-05-C, but another Scrub Report, SCR 0955, which describes the use of the ENTceps device and comments on performance such as "not a good seal" and "had trouble with foot pedal," did not generate a complaint.
We have reviewed your response dated March 31, 2010, and have concluded that the adequacy of the response cannot be determined at this time. Your firm states that SOP 1403 Rev F will be revised, employees retrained, etc., but the firm did not provide copies of the revised procedure and did not provide evidence that employees had received training on the revised procedure because the promised corrective actions had not occurred at the time of the firm's response.
Our inspection also revealed that your TLS3 Thermal Ligating Shears and the TLS4 RealHand Thermaseal are misbranded under section 502(t)(2) of the Act, 21 USC 352 (t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by under section 519 of the Act, 21 USC 360i, and 21 CFR Part 803 - Medical Device Reporting (MDR) Regulation. Significant deviations include, but are not limited to:
Failure to report to FDA no later than 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that a device that you market has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2). For example:
1. Complaint PCR 09-01-01-C states that seven jaw breaks occurred on the 35 cm TLS3 devices and one jaw broke on a 14 cm TLS3 device. The complaint was received on January 7,2009, and was not reported to the FDA as a malfunction within the 30-day timeframe. Each device that malfunctioned should have been reported as a separate MDR.
2. Complaint PCR 09-02-09-C states that a portion of the jaw of a TLS3 broke in the patient and was retrieved. Page two states that the jaw was not broken but portions of the silicone boot overheated and became brittle and resulted in the section of the boot being torn off. The complaint was received on February 20, 2009, and was not reported to the FDA as a malfunction within the 30-day timeframe.
3. Complaint PCR 09-05-08-C states that portions of the silicone boot of four RealHand Thermaseal, TLS4, devices used during a single laparoscopic procedure were fragmented. The complaint states that some silicone boots were lifting and fragmenting after firing only a few times. The complaint was received on May 12, 2009, and was not reported to the FDA as a malfunction within the 30 day timeframe. Each device that malfunctioned should have been reported as a separate MDR.
Based on your firm's 2008 risk analysis that resulted in the submission of MDR 2954339-2008-00004 for complaint PCR 08-08-05-C and the subsequent market withdrawal of the TLS3 and TLS4 that FDA classified as class II recalls RES 55721 and RES 55750 you are obligated to report the above complaints, and any other complaints related to the same device failure to FDA within a 30-day timeframe.
Your response dated March 31, 2010, is inadequate because you state that your firm will submit the three complaints noted on the FDA 483, PCR 08-08-05-C; PCR 0901-01-C; and PCR 09-05-08-C as MDRs by April 30, 2010. A search of the MAUDE database indicates that your firm has not submitted the MDR reports.
Also your firm's response is inadequate because your response states that your MDR procedure and CAPA 065 for complaint handling and Medical Device Reporting will be submitted sometime in the future. We have not received these documents.
If your firm wishes to submit MDR reports via electronic submission you can follow the directions stated at the following URL:
http://www.fda.gov/MedicalDevices/deviceregulationandguidance/guidancedocuments/ucm094529.htm#where
If you wish to discuss MDR reportability criteria, you may contact Sharon Kapsch, Branch Chief; Reporting Systems Monitoring Branch, to schedule further communications, at 301-796-6104 or by email at Sharon.Kapsch@fda.hhs.gov.
Our inspection also revealed that your TLS3 Thermal Ligating Shears and the TLS4 RealHand Thermaseal 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 device 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 deviations include, but are not limited to, the following:
Failure to submit any report required by paragraph 21 CFR 806.10(a) within ten working days of initiating such corrections or removal, as required by 21 CFR 806.10(b).
We have reviewed your response and have concluded that it is inadequate because the devices were falling apart or breaking during normal use and this poses a risk to health. In addition, the firm's own risk analysis identified this type of hazard (broken parts) as posing a serious risk. Therefore, the removal of the defective products does not meet the definition of a market withdrawal. The firm's second rationale for not reporting these events under 21 CFR 806 is also inadequate in that all of the information required under 21 CFR 806 was not submitted with the MDR.
A follow up inspection will be required to assure that corrections are adequate.
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. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: Sergio Chavez, Compliance Officer, United States Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions about the content of this letter please contact: Sergio Chavez at (510) 337-6886.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance 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.
Sincerely yours,
/s/
Barbara J. Cassens
District Director
San Francisco District
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