Inspections, Compliance, Enforcement, and Criminal Investigations
TMS International 12/13/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
White Oak Building 66
Silver Spring, MD 20993
December 13, 2012
VIA UNITED PARCEL SERVICE
Dear Mr. Hoogenboorn:
During an inspection of your firm located in Oldenzaal, Netherlands, on September 11, 2012, through September 12, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Mind Media BV Biofeedback Devices. 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. We received a response from you and Sjoerd van Leeuwen, Quality and Regulatory Officer, dated September 27, 2012, concerning observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. 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 action, as required by 21 CFR 820.100(a). For example:
a. Your firm did not include all quality data sources of nonconformance in your firm’s Corrective and Preventive Action (CAPA) procedure.
The adequacy of your firm’s response cannot be determined at this time. Although the draft version of the revised CAPA procedure was provided, there is no evidence of your firm implementing the updated procedure.
b. Your firm’s CAPA procedure does not address criteria for when an issue is to be included for follow up, nor does it describe the “Issues, Decisions, and Assumptions Log” that is used to follow-up on CAPA according to firm management.
The adequacy of your firm’s response is not adequate. Although your firm provided a draft revised CAPA procedure, the revised procedure, SOP-0013, General-Corrective and Preventive Actions, Rev. 1.4, does not address criteria for when an issue should be included for follow-up.
c. Your firm’s CAPA procedure does not indicate that an identified CAPA will investigate the cause of nonconformances, how a CAPA will be implemented and verified for effectiveness, or how a CAPA will be documented.
The adequacy of your firm’s response cannot be determined at this time. Your firm provided a draft revised CAPA procedure, SOP-0013, General-Corrective and Preventive Actions, Rev. 1.4, which appears to address investigating the cause of nonconformance. Additionally, the updated procedure notes that CAPAs will be verified for effectiveness and documented. Your firm’s proposed date for full implementation is December 1, 2012, and the corrective action taken will be verified during internal audits. However, necessary documentation and information, including evidence of implementation of your firm’s revised CAPA procedure, was not provided in the response.
2. Failure to document all activities required by 21 CFR 820.100, and their results, as required by 21 CFR 820.100(b). For example: a corrective and preventive action was opened and the correction implemented in response to (b)(4). The devices were determined to have been damaged during (b)(4). There is no documentation of the investigation that resulted in the corrective action or documentation of the corrective action being implemented. As a result, your firm implemented a corrective action without documenting the investigation.
The adequacy of your firm’s response cannot be determined at this time. Although your firm noted that it could not produce documentation for a CAPA that had already been implemented, your firm’s management noted the CAPA is currently being verified for effectiveness and promised to correct the lack of documentation by December 1, 2012. However, no documentation to support verification of effectiveness was provided.
3. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example: your firm’s procedures describing the control of nonconforming product does not describe how nonconforming product will be identified, segregated, or marked to prevent misuse, nor how the ultimate disposition of the product will be documented.
The adequacy of your firm’s response cannot be determined at this time. Your firm’s response notes an adaptation of current SOPs to describe specifically how nonconforming product will be identified, segregated, or marked to prevent misuse, and how the ultimate disposition of the product will be documented by December 1, 2012. In addition, it was stated that your firm will verify the effectiveness of the corrective action during an internal audit. However, no revised SOPs or evidence of planned implementation was provided for review.
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. 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 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 action (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 #379460 when replying. If you have any questions about the contents of this letter, please contact: Tanisha Hithe at 301-796-5524 or via fax at 301-847-8128.
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