Inspections, Compliance, Enforcement, and Criminal Investigations
Circulatory Technology Inc 7/12/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New York District|
158-15 Liberty Ave.
Jamaica, NY 11433
July 12, 2010
WARNING LETTER NYK-2010-23
Circulatory Technologies, Inc.
21 Singworth Street
Oyster Bay, New York 11771-3703
Dear Mr. Tamari:
During an inspection of your firm located in Oyster Bay, New York on March 9 through 15, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Bigger Better Bladder. 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 (C.F.R.), Part 820. These violations include, but are not limited to, the following:
1. Failure to establish and maintain adequate procedures for implementing corrective and preventive action to include requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems, as required by 21 CFR 820.100(a)(1). For example, your Firm has not established Corrective and Preventive Action procedures.
2. Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate, verification, review and approval of design changes before their implementation, as required by 21 CFR 820.30(i).
For example, procedures for engineering changes to the Bigger Better Bladder were not established and maintained. Additionally, acceptance criteria for validation activities were not established on the Bigger Better Bladder product prior to re-validation of the subsequent lot #9910-21317 to ensure the design change (#383 Rev. 1) corrected the leaking failure.
3. Failure to establish and maintain procedures to evaluate and select potential suppliers, contractors and consultants on the basis of their ability to meet specified requirements, including quality requirements, as required by 21 CFR 820.50(a)(1).
For example, no written procedures were established to ensure that contractors and consultants are selected on the basis of their ability to meet specified requirements.
4. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints; as required by 21 CFR 820.198(a).
For example, complaints were processed regarding the Bigger Better Bladder product without written procedures to ensure that the complaints had been reviewed, handled, documented and investigated in a timely manner by a formally designate unit.
Our inspection also revealed that your Bigger Better Bladder 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 (MDR) regulation. Significant deviations include, but are not limited to, the following:
Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. For example, your firm has not developed, maintained and implemented procedures for Medical Device Reporting (MDR), that will specify the timeframe for contacting the FDA, and procedures for investigation and supplemental reporting to FDA.
Our inspection also revealed that your Bigger Better Bladder 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 806 - Reports of Corrections and Removals regulation. Significant deviations include, but are not limited to, the following:
Failure to send to the FDA within 10 days of initiating the correction or removal a report of the required information regarding device correction and removal actions, as required by 21 CFR 806.10(b). For example, your firm identified a failure of the Bigger Better Bladder, lot 9910-18907, where the unit was leaking in the field between the bladder and the end cap. As a result of this failure, all of the customers who purchased the device were notified of the removal by your firm. However, FDA was not notified of the voluntary removal of the device by your firm.
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, pre market 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 response should be sent to:
Lillian C. Aveta
New York District Office, Compliance Branch
Food and Drug Administration
158·15 Liberty Ave.
Jamaica, NY 11433
If you have any questions about the content of this letter please contact Ms. Aveta at 718-662-5576.
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:
Ronald M. Pace
New York District