| Public Health Service Food and Drug Administration |
Baltimore District Office 6000 Metro Drive, Suite 101 Baltimore, MD 21215 Telephone: (410) 779-5454 Fax: (410) 779-5703 |
Department of Health and Human ServicesFEI:3007510735
WARNING LETTER
CMS # 229274
October 4, 2011
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. John Herod, President
Advantageous MD, LLC
1728 Virginia Beach Blvd.
Suite 115
Virginia Beach, VA 23454
Dear Mr. Herod:
During an inspection of your firm located in Virginia Beach, Virginia on September 7 and September 13, 2011, investigators from the United States Food and Drug Administration (FDA) determined that your firm is a specification developer of the AMD 6605 TENS/NMES Stimulator, the ASD 150 Cervical Traction Collar and the ASD 550 Lumbar Traction Belt. 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. Significant violations include, but are not limited to, the following:
- Failure to ensure that the methods used in, or the facilities or controls used for its manufacture, packing, storage, or installation are in conformity with the Current Good Manufacturing Practice (CGMP) requirements for devices which are set forth in the Quality System regulation, as specified in Title 21 CFR Part 820.
For example:
- Your firm has not established procedures for design control, document control, finished device acceptance activities, control of product that does not conform to specific requirements and Medical Device Reporting (MDR).
- Your firm has no record of design activities for the AMD 6605 TENS/NMES Stimulator.
- Failure to maintain complaint files, to comply with 21 CFR 820.198.
For example:
- Your firm did not consider any of the following events to be complaints; no complaint records were created and no investigations were performed:
i. A patient called and stated that an AMD 6605 TENS/NMES Stimulator had caused skin irritation and burns.
ii. Two AMD 6605 TENS/NMES Stimulators (serial numbers (b)(4) and (b)(4)) were returned to your firm by patients and identified as being “broken”.
iii. A meeting conducted at your firm on June 24, 2011 involved discussion of a complaint received that stated an AMD 6605 TENS/NMES device was not working properly.
iv. A meeting conducted at your firm on July 29, 2011 was held to discuss a complaint received regarding a hand pump on an ASD 150 Cervical Traction device that was not working.
- Your firm has not adequately established and maintained procedures for receiving, reviewing and evaluating complaints by a formally designated unit. “Policy 1.4. Complaint Process” is not being followed. The policy states that the employee receiving a complaint or praise shall complete a Company Complaint Form. No Company Complaint Forms have been completed. This policy is not adequate because it does not describe a method for determining if an investigation is necessary, how corrective and preventive actions are implemented and evaluated, and how to determine if a complaint must be reported to FDA.
- Failure to document corrective and preventive action activities and/or results, as specified in 21 CFR 820.100.
For Example:
- Your firm has not adequately established procedures for corrective and preventive action. “Policy 4.1. Performance Improvement Plan” is not being followed and is not adequate.
- Your firm identified a problem with defective O-rings in the cervical and lumbar traction belts. With no corrective action activities being documented; changes in production processes and materials at the contract manufacturing facility were implemented and 100% of the devices at your facility were inspected and rework activities performed.
Our inspection also revealed that your firm’s AMD 6605 TENS/NMES Stimulator 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 furnish any material or information respecting the AMD 6605 TENS/NMES Stimulator that is required by or under section 519, 21 U.S.C. 360i, and 21 CFR Part 803.
For example:
On 5-12-10 your firm was contacted by a patient who experienced skin irritation and burns as a result of using the AMD 6605 TENS/NMES Stimulator. The event was not identified as a complaint and was not reviewed, evaluated or reported to the FDA.
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 Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all 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. 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 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: U.S. Food and Drug Administration, Attention: Evelyn Bonnin, District Director, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. Refer to the Unique Identification Number (CMS # 229274) when replying. If you have questions regarding any issues in this letter, please contact Ms. Leslie at (757) 483-7042.
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 closeout 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 to bring your products into compliance.
Sincerely,
/S/
/S/
Evelyn Bonnin
District Director
Baltimore District Office
Baltimore District Office
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