Inspections, Compliance, Enforcement, and Criminal Investigations
Shoney Scientific India 11/20/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire A venue|
Silver Spring. MD 20993
November 20, 2013
Via United Parcel Service
Mr. Rajesh R. Shoney
Chief Executive Officer
Shoney Scientific India
A30/B, Industrial Estate, Thattanchavady
Dear Mr. Shoney:
During an inspection of your firm located in Pondicherry, India,from July 2, 2013, through July 5, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Disposable Biopsy Punches, Dermal Curettes, Liposuction Cannulas, Cervical Dilators, and Tongue Cleaners. 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 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:
1. Failure to ensure, when the results of a process cannot be fully verified by subsequent inspection and test, that the process shall be validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a). For example, the validation for Equipment # (b)(4), (b)(4) Machine, was inadequate in that temperature parameters of the (b)(4) machine were not identified and/or documented as part of the validation study. Additionally, the validation for the (b)(4) Machine did not test temperature extremes of the (b)(4) machine. The (b)(4) Machine is used to produce the (b)(4) for (b)(4) for the Disposable Biopsy Punch.
2. Failure to establish procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met, as required by 21 CFR 820.75(b). For example, your firm has not established a procedure to monitor and control process parameters for the (b)(4) Machine.
3. Failure to establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained, as required by 21 CFR 820.72(a). For example, the calibration activities of equipment utilized in the manufacture of the Disposable Biopsy Punch have not been documented.
4. Failure to establish procedures for identifying training needs and ensuring that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). For example, Procedure D/QSP/TRAI/04, Rev. 03, Training, states the following: “Training will be provided to the employees based on the need. These Trainings will be recorded in the Training Register.” According to your firm’s Management Representative, training covering ISO Awareness, Tag System, Designated Area, Personal Hygiene, Precautions with Different Machine, Use of Safety Wear, and On Job training were not documented as part of the Employee Training Register since 2010.
The Disposable Biopsy Punch is also adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. The Disposable Biopsy Punch is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction this device into interstate commerce for commercial distribution, intended for a use different from the intended use of a legally marketed device in the generic type of device described at 21 CFR 872.4565 (Punch, Biopsy, Surgical), without submitting a premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(b).
Devices classified under 21 CFR 872.4565 (Punch, Biopsy, Surgical) are exempt from premarket notification unless they exceed the limitations on exemption at 21 CFR 872.9(a). There is evidence that the Disposable Biopsy Punch is intended for uses that are different from those of legally-marketed devices classified under 21 CFR 872.4565. Generic devices of this type are “hand-held devices intended to perform various tasks in general dentistry and oral surgery procedures.” However, according to your firm’s website (www.shoneysi.com), the Disposable Biopsy Punch indications for use include, but are not limited to, “correcting vitiligo. The smaller sizes of the biopsy punch are also used for hair transplant.” Since the Disposable Biopsy Punch has a different intended use, it exceeds the limitations described in 21 C.F.R. 872.9(a) and is not exempt from premarket notification.
For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Our office requests that Shoney Scientific India immediately cease activities that result in the misbranding or adulteration of the Disposable Biopsy Punch, such as the commercial distribution of the device for the uses discussed above.
Given the serious nature of the violations of the Act, the devicesmanufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you if your firm’s response appears to be adequate, and we may need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
Also, U.S. federal agencies may be advised of the issuance of 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.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review.
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #411720 when replying. If you have any questions about the contents of this letter, please contact: LaShanda M. Long, Chief, General Surgery Devices Branch, Office of Compliance, at (301) 796-5465 or via fax at (301) 847-8137.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Steven D. Silverman
Office of Compliance
Center for Devices and
Shoney Scientific India
West 223, 720 Saratoga Dr.
Waukesha, Wisconsin 53186