Inspections, Compliance, Enforcement, and Criminal Investigations
P-Ryton Corporation 18-Dec-07
Department of Health and Human Services
Public Health Service
New York District
December 18, 2007
RETURN RECEIPT REQUESTED
5-04 50th Avenue
Long Island City, New York 11101
Dear Mr. Palumbo:
During an inspection of your firm located in Long Island City, New York on October 17, 22, and 29, 2007, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures Tree, reference # TR1000, a cosmetic skin care device. 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 is intended 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, its 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.
These violations include, but are not limited to, the following:
1. Failure to establish and maintain the Quality System procedures and instructions, as required by 21 CFR 820.20(e). For example, your firm has not established and maintained quality system procedures for the following activities for your Tree device, reference # TR1000:
• Document Controls, as required by 21 CFR 820.40;
• Acceptance Activities, as required by 21 CFR 820.80(b) and (d);
• Nonconforming Product Controls, as required by 21 CFR 820.90;
• Inspection, Measuring, and Test Equipment Controls, including calibration of the
digital multi-meter test device, as required by 21 CFR 820.72, and
• Complaint Handling, as required by 21 CFR 820.198.
2. Failure to maintain device master records that include, or refer to the location of, device specifications including appropriate drawing, composition, formulation, component specifications and software specifications, as required by21 CFR 820.181(a). For example, your firm does not have a device master record for the Tree, reference # TR1000, which contains or identifies the location of the device and component specifications, and other required information for the manufacturing processes.
3. Failure to establish and maintain device history records, as required by 21 CFR 820.184. For example, your firm has not established or maintained the required device history record for the Tree, reference # TR1000, manufactured at this facility.
Furthermore, your Tree, reference # TR1000, is misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), in that the device was not included in a list required by section 510(j) of the Act, 21 U.S.C. 3609(j).
Additionally, our inspection revealed that your Tree device, reference # TR1000, is also 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 C.F.R. Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
•Your firm failed 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 written MDR procedures for internal systems that provide for timely and effective evaluation of events that may be subject to MDR requirements; a standardized review process or procedure for determining when an event meets the criteria for reporting; and timely transmission of complete medical device reports to FDA.
You 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 (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your written response should be sent to Anna Alexander, Compliance Officer, U.S. Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, New York 11433. If you have any questions about this letter, please contact Compliance Officer Anna Alexander at (718) 662-5683.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Otto D. Vitriol