Inspections, Compliance, Enforcement, and Criminal Investigations
Advanced Orthogonal Equipment, Inc. 1/6/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
RETURN RECEIPT REQUESTED
January 6, 2012
Dr. George Stanford Pierce
Advanced Orthogonal Equipment, Inc.
2201 62nd Ave N
Saint Petersburg, Florida 33 702
Dear Dr. Pierce:
During an inspection of your firm located in Saint Petersburg, Florida, on August 18, 2011, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Advanced Orthogonal Percussion Adjusting Instrument. 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.
This inspection 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, 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. 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, your firm has not established and maintained design control procedures.
2. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, your firm has not established and maintained procedures for Corrective and Preventive Action.
3. 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 does not have formal procedures for documenting, reviewing, and evaluating complaints, and does not identify a designated unit for these activities.
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, your firm does not have written procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.
5. Failure to establish and maintain 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 and maintained procedures requiring the performance of quality audits at defined intervals.
We received a response from you dated August 27, 2011, concerning our investigator's observations noted on the Form FDA 483 (FDA 483), Inspectional Observations, which was issued to your firm. The response is inadequate because it did not provide any specific plan or evidence of any corrections, corrective actions, and systemic corrective actions to address the FDA 483 observations.
Our inspection also revealed that your firm's Advanced Orthogonal Percussion Adjusting Instrument 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.
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 has not developed, maintained, and implemented MDR procedures.
We reviewed your firm's response and conclude that it is not adequate. The response did not provide any specific plan or evidence of any corrections, corrective actions, and systemic corrective actions to address this observation.
Our inspection also revealed that the Advanced Orthogonal Percussion Adjusting Instrument is adulterated under Section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to Section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under Section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under Section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by Section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by Section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
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: Salvatore N. Randazzo, Compliance Officer, Florida District Office, 555 Winderly Place, Suite 200, Maitland, Florida, 32751. Refer to the Unique Identification Number 243494 when replying. If you have any questions about the contents of this letter, please contact: Salvatore N. Randazzo at 407-475-4712.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at yol.lr 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