Inspections, Compliance, Enforcement, and Criminal Investigations

Combo AG 1/12/15

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993 

JAN 12, 2015

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
 
Mr. Adrian Giger
Chief Executive Officer
Combo AG Medizintechnik
Tugginerweg 3
CH-4503 Solothurn
Switzerland
 
Dear Mr. Giger:
 
During inspections of your firm located in Langerdorf, Switzerland, and Lommiswil, Switzerland, on September 8, 2014, through September 11, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Giger Medical Device with Biofeedback Mechanism, a biofeedback device. 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 to affect the structure or function of the body.
 
These inspections revealed that this device is 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, its 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 dated September 25, 2014, concerning our investigator’s observations noted on the Forms FDA 483 (FDA 483), List of Inspectional Observations, that were 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 to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). For example, there are no documented procedures to govern the design control process. Additionally, design documentation for your firm’s device was incomplete in that there were no design development plans, design reviews, and design changes.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response did not address the device’s design documentation deficiencies. Additionally, your firm failed to provide the design control procedures, and evidence of their implementation, for review.
 
2.    Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, there are no documented procedures to govern the handling of customer complaints. Additionally, there was no documentation of the investigation, for a customer complaint, pertaining to the device’s software.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response did not address complaint documentation deficiencies. In addition, your firm did not provide the new complaint handling procedures, and evidence of their implementation, for review.
 
3.    Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). For example, there are no documented procedures to govern corrective and preventive actions. Additionally, corrective and preventive actions were not documented for a change to the device’s software in response to a customer complaint.
 
We reviewed your firm’s response and conclude that it is not adequate.  Your firm’s response did not address creating a CAPA file for the device’s software change to document the investigation, actions, and activities that were performed. In addition, your firm failed to provide the new CAPA procedures, and evidence of their implementation, for review.
 
4.    Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example, there are no procedures to govern purchasing controls or supplier qualification.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response did not address whether your firm plans to evaluate current suppliers in accordance with established requirements. Your firm did not indicate whether a retrospective review of supplier information will be conducted to determine if purchased products meet specified requirements and have been adequately controlled.  In addition, your firm failed to provide the new purchasing and supplier controls procedures, and evidence of their implementation, for review.
 
5.    Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). For example, there are no procedures for documenting incoming product and/or material acceptance activities.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not address this violation in its response.
 
6.    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, there are no procedures to govern the control of nonconforming product and/or material.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not address this violation in its response.
 
7.    Failure to establish and maintain procedures to control all documents that are required by 21 CFR 820, as required by 21 CFR 820.40. For example, there are no documented procedures to govern how quality system related documents are controlled.  Additionally, the computer configuration checklist and the work instruction for chip programming are uncontrolled documents.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response did not address how your firm plans to control documentation for the device manufacture.  In addition, your firm failed to provide the new document control procedures, and evidence of their implementation, for review.
 
8.    Failure to establish and maintain procedures for quality audits and to conduct such audits to assure that the quality system complies with established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. For example, there are no procedures to govern internal quality audits. Additionally, internal quality audits have not been performed.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response failed to identify a timeline of planned internal audits. In addition, your firm failed to provide the new internal audit procedures, and evidence of their implementation, for review.
 
9.    Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer’s established quality policy and objectives, as required by 21 CFR 820.20(c). For example, there are no procedures to govern management reviews.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response failed to identify a timeline of planned management reviews. In addition, your firm failed to provide the new management review procedures, and evidence of their implementation, for review.
 
10.    Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). For example, there are no procedures to govern training activities.
 
The adequacy of your firm’s response cannot be determined until your firm has completed and submitted evidence of implementation of its training procedures.
 
Our inspection also revealed that your firm’s Giger Medical Device with Biofeedback Mechanism is 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 803 – Medical Device Reporting (MDR). Significant violations include, but are not limited to, the following:
 
11.    Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. For example, there are no procedures to govern adverse event reporting.   
 
The adequacy of your firm’s response cannot until your firm has completed and submitted evidence of implementation of its MDR procedures.
 
Given the serious nature of the violations of the Act, 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 regarding the adequacy of your firm’s responses and the 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 (which must address systemic problems) 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 Inspections Support Branch, White Oak Building 66, Rm. 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #443070 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch at +1 (301) 796-5587 (telephone), or +1 (301) 847-8139 (fax).
 
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. 
 
 
Sincerely yours,
/S/                                                           
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
   Radiological Health

Page Last Updated: 12/17/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English