| | |
 Department of Health and Human Services
| Public Health Service
Food and Drug Administration |
| | Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996 |
September 23, 2011
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply please refer to Warning Letter SEA 11-24
James S. Jacobson
President and Owner
X-Ray Support, Inc.
3020 N. Sullivan Rd., Suite D
Spokane Valley, Washington 99216
WARNING LETTER
Dear Mr. Jacobson:
During an inspection of your firm located in Spokane Valley, Washingtonon May 20, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Dental X-Ray Automatic Film Processors. 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 are intended 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 an email response from you dated May 24, 2011, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations that was issued to your firm. You sent an email to the district stating that the firm would no longer build the ImageMax and requested that the firm be “removed from” the FDA “list”. Therefore, your firm has not formally responded to each of the FDA 483 items. Additionally, a review of the firm’s website on June 14, 2011, and an updated review of the website, http://www.imagemax.us/, on September 7, 2011, demonstrated that your device was still available for sale. Since your firm is continuing to manufacture and distribute the device, your firm is subject to the requirements of the Quality System regulation as set forth in 21 CFR 820. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a). For example, your firm has not established procedures for implementing corrective and preventive actions.
2. 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, your firm has not established procedures for design control activities.
3. 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, your firm has not established procedures for purchasing controls activities.
4. Failure to establish and maintain procedures to control all documents, as required by 21 CFR 820.40. For example, your firm has not established procedures to control all documents.
5. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. For example, your firm has not established procedures for conducting quality audits.
6. Failure to maintain a quality system record (QSR), as required by 21 CFR 820.186. For example, your firm has not established a quality system record.
Upon request by the investigator for the above referenced procedures, you indicated the requested procedures were located in your head.
Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal years 2008, 2009, 2010, and 2011.
Therefore all of your firm’s devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(o)), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).
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 response should be sent to the US Food and Drug Administration, Attention: Brenda L. Reihing, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any questions about the content of this letter please contact Brenda L. Reihing at (425) 483-4899.
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/
Charles M. Breen
District Director
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