Inspections, Compliance, Enforcement, and Criminal Investigations
Sleep Devices, Inc. 28-Mar-07
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Ste. 200
RETURN RECEIPT REQUESTED
March 28, 2007
Najeeb A. Zuberi, M.D.
Sleep Devices, Inc.
506 W. Cherry Street
Kissimmee, Florida 34741
Dear Dr. Zuberi:
During an inspection of your firm located at the above address on January 16, 2007, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Sona pillows for snoring and sleep apnea. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), these products are [medical] 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 this device is adulterated within the meaning of section501(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 (C.F.R.), Part 820.
These violations include, but are not limited to, the following:
1. Your firm has not established and implemented written procedures for the following:
a. Your firm has not established procedures to control the design process, as required by 21 CFR 820.30(a).
b. Your firm has not established and does not maintain written procedures to ensure that all purchased product and services conform to specified requirements, as required by 21 CFR 820.50.
c. Your firm failed to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 100(a).
d. Your firm failed to establish and maintain written procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR 820.198(a), and no written Medical Device Report (MDR) procedures have been established and maintained, as required by 21 CFR 803.17.
e. Your firm failed to maintain device master records (DMRs) that include or refer to the location of device specifications as required by 21 CFR820.181(a).
f. Your firm failed to establish procedures to ensure that device history records for each batch, lot or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record and the Quality System Regulation as required by 21 CFR 820.184
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 response should be sent to Brant M. Schroeder, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751, (407) 475-4763.
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.
Emma R. Singleton
Director, Florida District