Inspections, Compliance, Enforcement, and Criminal Investigations
SystemsOne, LLC 3/6/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
RETURN RECEIPT REQUESTED
March 6, 2012
Thomas S. Arthur
200 SW Atlanta Ave
Stuart, FL 34994
Dear Mr. Arthur:
During an inspection of your firm located in Stuart, Florida, on November 14, 2011, through November 16, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Electrophysiology Systems Integrator (EPSI). 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. Your firm’s response to the Form FDA 483 (FDA 483), dated December 30, 2011, was not reviewed because it was not received within fifteen business days of issuance of the FDA 483. The response may be evaluated along with any other written material provided in response to the violations cited in this Warning Letter. These violations include, but are not limited to, the following:
1. Failure to establish and maintain adequate procedures for validating the device design, as required by 21 CFR 820.30(g). For example, your firm’s Chief Operating Officer stated that your firm does not have a software validation procedure and has no documentation of software testing.
2. Failure to establish and maintain adequate 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, your firm’s Chief Operating Officer stated that your firm does not have design control procedures, including risk analysis procedures.
3. Failure to establish and maintain adequate procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a). For example, your firm’s Chief Operating Officer stated that your firm does not have procedures for corrective and preventive action.
4. Failure to document corrective and preventive actions and their results, as required by 21 CFR 820.100(b). For example, your firm’s Chief Operating Officer stated that your firm failed to document corrective actions taken in the past according to the Quality System Regulation.
5. Failure to establish and maintain adequate procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50(a). For example, your firm’s Chief Operating Officer stated that your firm does not have purchasing control procedures.
6. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, your firm’s Chief Operating Officer stated that your firm does not have a formal complaint handling procedure.
7. Failure to maintain an adequate record of the investigation, when an investigation is made under 21 CFR 198, by the formally designated unit identified in paragraph (a) of 21 CFR 198. The record of investigation shall include: (1) the name of the device; (2) the date the complaint was received; (3) any device identifications and control numbers used; (4) the name, address, and phone number of the complainant; (5) the nature and details of the complaint; (6) the dates and results of the investigation; (7) any corrective action taken; and (8) any reply to the complainant, as required by 21 CFR 820.198(e). For example, multiple complaints listed in your firm’s complaint log, which is your firm’s only source of documenting complaints, did not include the following:
a. The name of the device,
b. The date the complaint was received,
c. The name, address, and phone number of the complainant,
d. The dates and results of the investigation,
e. Any corrective action taken, and
f. Any reply to the complainant.
8. Failure to maintain device master records (DMRs) and to ensure that each DMR is prepared and approved in accordance with 21 CFR 820.40, as required by 21 CFR 820.181. For example, your firm’s Chief Operating Officer stated that your firm lacks any written process or quality procedures covering the assembly or testing of devices.
9. Failure to establish and maintain adequate procedures to ensure that Device History Records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the Device Master Record, as required by 21 CFR 820.184. For example, your firm’s Chief Operating Officer stated that your firm has no device history records.
10. Failure to establish and maintain adequate 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. These quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited, as required by 21 CFR 820.22. For example, your firm’s Chief Operating Officer stated that your firm has no written internal quality audit procedure and has not conducted any internal audits according to the Quality System Regulation.
Our inspection also revealed that your firm’s EPSI 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 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:
Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. For example, your firm’s Chief Operating Officer stated that your firm has no written MDR procedure.
Your firm 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, 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 violations 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, as well as 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. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to: U.S. Food and Drug Administration, Florida District, Attention: Angela Glenn, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, FL 32751. Refer to the Unique Identification Number CMS Case #270202 when replying. If you have any questions about the contents of this letter, please contact: Mr. Ronnie E. Jackson at (407) 475-4734 or (407) 475-4769.
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.
Emma R. Singleton
Director, Florida District