- Eolane Vailhauques
- Issuing Office:
- Center for Devices and Radiological Health
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire A venue|
White Oak Building 66
Silver Spring, MD 20993
VIA UNITED PARCEL SERVICE
49 Rue Super Nova
Z.l.de Bel Air
Dear Mr. Bureau:
During an inspection of your firm located in Vailhauques, France on September 18, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures galvanic skin response measurement 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 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 responses from Mr. Pascal Pottier, Quality Manager, dated October 1, 2015, and October 27, 2015, concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of lnspectional Observations, which was issued to your firm. Your firm's response dated October 27, 2015, to FDA 483 was not reviewed because it was not received within fifteen business days of issuance of the FDA 483. This response will be evaluated along with any other written material provided in response to the violations cited in this Warning Letter. We address your firm's October 1, 2015 response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to adequately ensure that 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 procedure, as required by 21 CFR 820.75. For example, your firm has not adequately validated the (b)(4), such as (b)(4), used to manufacture galvanic skin response measurement devices. In addition, your firm has not established a procedure for monitoring and controlling the parameters of validated processes.
We reviewed your firm's response and conclude that they are not adequate. The response indicated that your firm's requirements, specifications, and processes are compliant with ISO/IPC-610 Acceptability of Electronic Assemblies. However, your firm did not provide documentation to assure that the (b)(4) are adequately validated. Specifically, your firm did not provide approved protocols, and procedures for monitoring and controlling operating parameters. Also, your firm did not provide documentation of a comprehensive analysis to demonstrate that all manufacturing processes are adequately validated, and that corrective actions were taken for any identified deficiencies, as appropriate.
2. Failure to establish and maintain adequate procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). For example, your firm's CAPA procedure, "Actions Correctives et Preventives," (b)(4), Rev F, dated December 19, 2012:
a) Does not include requirements for verifying or validating the corrective and preventive action to ensure that such action does not adversely affect the finished device.
b) Does not include the requirement of implementing and recording changes in methods and procedures needed to correct and prevent quality problems.
c) Does not ensure that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems.
We reviewed your firm's response and conclude that they are not adequate. The response included a copy of your firm's updated CAPA procedure. However, the procedure does not address the above deficiencies. In addition, the response did not indicate if personnel will be trained on the updated CAPA procedure. Your firm did not provide documentation of a comprehensive analysis of CAPAs to ensure that the CAPAs were adequately implemented.
3. Failure to adequately validate computer software for its intended use according to an established protocol, as required by 21 CFR 820.70(i).
For example, your firm did not have documentation to demonstrate that the (b)(4) computer data processing software, developed in house, was validated for its intended use. Your firm has installed and has been utilizing the software since 2005 for documenting and monitoring nonconformances with customer complaints, suppliers, internal/external audits, CAPA and internal facility defects.
We reviewed your firm's response and conclude that they are not adequate. The response included a copy of your firm's procedure, "(b)(4)." The response indicated that the software is cleared for use; however, your firm did not provide software validation documentation. The response did not include documentation that your firm has performed a comprehensive analysis of additional software packages to ensure that they were adequately validated. The response did not indicate if personnel will be trained on how to operate the (b)(4).
4. Failure to establish and maintain adequate procedures to ensure that device history records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the Device Master Record (DMR), as required by 21 CFR 820.184. For example, your firm has not maintained copies of the primary identification labels used for each production unit in the DHRs. In addition, the DHRs for Sudoscan, Serial Number 6866, do not have the identification information for inspection and/or test equipment used for the finished product acceptance activities.
We reviewed your firm's response and conclude that they are not adequate. Your firm created binders to maintain a hard copy of device labels for its master unit and for hands and feet electrodes labels. Your firm updated its final release form to include a new action step for printing, verifying, and recording for the binders of the primary identification labels, and to include information related to the inspection and/or test equipment. However, your firm did not provide documentation of a comprehensive analysis of additional DHRs to ensure that the devices are manufactured in accordance with the DMRs. Your firm did not provide personnel training records on the revised final release form.
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 Ill 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 action (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. We will notify you regarding the adequacy of your firm's response and the need to re-inspect your firm's facility to verify that the appropriate corrections and/or corrective actions have been made.
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 3523, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case# 486438 when replying. If you have any questions about the contents of this letter, please contact: Chief, Foreign Enforcement Branch, at firstname.lastname@example.org
(email), or +1 (240) 402-4020 (phone), or +1 (301) 847-8138 (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 lnspectional 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.
CAPT Sean M. Boyd, MPH, USPHS
Office of Compliance
Center for Devices and
lmpeto Medical Inc.
8910 University Center Ln
San Diego, CA 92122