Inspections, Compliance, Enforcement, and Criminal Investigations
Behavioral Therapeutics, LLC. 24-Apr-08
Department of Health and Human Services
Public Health Service
Center for Devices and
APR 24 2008
VIA FEDERAL EXPRESS AND FACSIMILE
Robert F. Reynolds, Ph.D.
Chief Executive Officer
Connecticut Educational Services
770 Saybrook Road, Building B
Middletown, Connecticut 06457
Timothy H. Morgan
Behavioral Therapeutics, LLC
4920 Commerce Parkway
Warrensville Heights, Ohio 44128-5943
Dear Messrs. Reynolds and Morgan:
During an inspection of Connecticut Educational Services (CES) located in Middletown, Connecticut on October 18, 2007, through October 24, 2007, and an inspection of Behavioral Therapeutics, LLC, located in Warrensville Heights, Ohio on December 10, 2007, through December 18, 2007, investigators from the United States Food and Drug Administration (FDA) determined that your firms market the Good Vibrations device. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), Good Vibrations 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 any function of the body.
The Good Vibrations device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do 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 ( IDE) 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 you did not notify the agency of your 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) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency [21 CFR 807.81(b)]. The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122 html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
These inspections also 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations(21 CFR), Part 820. We received a response from Mr. Timothy Morgan dated February 13, 2008, concerning our investigator's observations noted on the Form FDA-483, List of Inspectional Observations, that was issued to Mr. Morgan. We address this response below, in relation to each of the noted violations. 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. For example:
a) Neither Behavioral Therapeutics nor Connecticut Educational Services has established or maintained plans or procedures for controlling the design of the device, including design or development plans and procedures for design input, design output, design review, design verification, design validation, design transfer, design changes, and Design History File (DHF).
b) The following changes were made to the Good Vibrations device without review, approval, or documentation:
i. A reset button was added to the teacher unit;
ii. The charting software was revised;
iii. The voltage to the vibratory motor was lowered to reduce the noise level on the receiving unit; and,
iv. You have not provided any evidence of establishing or maintaining a Design History File.
2. Failure to maintain Device Master Records (DMRs) in accordance with 21 CFR 820.40, as required by 21 CFR 820.181.
For example, neither Connecticut Educational Services nor Behavioral Therapeutics has maintained DMRs to include or refer to the location of the following:
a) Device specifications, including appropriate drawings, composition, formulation, component specifications, and software specifications;
b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;
c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;
d) Packaging and labeling specifications , including methods and processes used; and,
e) Installation, maintenance, and servicing procedures and methods.
3. Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100.
For example, your firms have not established or maintained corrective preventive action (CAPA) procedures to include requirements for:
a) Analyzing service records, complaints, returned product, or other quality problems;
b) Investigating the cause of non-conformities;
c) Identifying the actions needed to correct and prevent recurrence of nonconforming product and other quality problems;
d) Verifying or validating corrective or preventive actions to ensure that such action is effective and does not adversely affect the finished device;
e) Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;
f) Ensuring that information related to quality problems or non-conforming product is disseminated to those directly responsible for ensuring the quality of such product;
g) Submitting relevant information for management review; and
h) Documenting all required CAPA activities.
4. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198.
For example, your firms have not established or maintained complaint handling procedures to ensure that:
a) Complaints are processed in a uniform and timely manner;
b) Oral complaints are documented;
c) Complaints are evaluated to determine whether an investigation is necessary;
d) Failure of a device, labeling, or packaging to meet specifications is reviewed, evaluated, and investigated;
e) Complaints representing a reportable event under Part 803 are promptly reviewed, evaluated, and investigated;
f) Records of investigations are maintained by a formally designated unit;
g) When the complaint unit is located at a site separate from the manufacturing site, records of complaints and investigations are readily accessible to the manufacturing establishment; and,
h) When the complaint unit is located outside the United States, records are reasonably accessible at a location within the United States or at the initial distributor.
5. Failure to establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications, as required by 21 CFR 820.90(b)(2).
For example, 30 Good Vibrations units that were identified as vibrating too loudly were returned to the contract manufacturer [redacted] to be reworked. The units were never identified or documented as nonconforming product. Since there is no system in place to capture the quality data, it is not possible to trend the data or detect quality problems associated with the device.
6. Failure to establish and maintain procedures to ensure that device history records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR, as required by 21 CFR 820.184.
For example, your firms have not established or maintained procedures to ensure that DHRs for each batch, lot, or unit are maintained to ensure that the device is manufactured in accordance with the DMRs required specifications. There are no DHRs for the [redacted] devices already manufactured and no lot or serial number to identify individual units.
7. Failure to establish and maintain procedures for finished device acceptance toensure that each production run, lot, or batch of finished device meets acceptance criteria, as required by 21 CFR 820.80(d).
For example, your firms have not established or maintained procedures for acceptance or rejection of finished device production runs, lots, or batches for the Good Vibrations device. Finished devices were released for distribution without documented acceptance.
8. Failure to establish and maintain quality system procedures and instructions for the device, as required by 21 CFR 820.20(e)
For example, neither Behavioral Therapeutics, nor Connecticut Educational Services, has any Quality System procedures in place.
Our inspection also revealed that your Good Vibrations device 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 Act, 21 U.S.C. by or under section 519 of the 360i, and 21 C.F.R. Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
You failed to develop, maintain, and implement written MDR procedures that provide for: (1) timely and effective identification, communication, and evaluation of events that are subject to MDR requirements, (2) a standardized review process for determining when an event meets the criteria for reporting, and (3) timely transmission of complete medical device reports to FDA and/or manufacturers, as required by 21 CFR 803.17(a).
Our inspection also revealed that the Good Vibrations device is adulterated under section 501(o) of the Act, 21 U.S.C. 352(o), in that the device was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under 21 U.S.C 360, the device was not included in a list required by 21 U.S.C. 360(j), and a notice or other information respecting the device was not provided to the FDA as required by 21 U.S.C. 360(k).
We received a response from Timothy H. Morgan, President of Behavioral Therapeutics, dated February 13, 2008, concerning our investigator's observations noted on Form FDA 483, List of Inspectional Observations that was issued to you. This response states that you have requested your contract manufacturer to discontinue Good Vibrations manufacturing activities and to quarantine any finished devices that you will not accept new orders for Good Vibrations, that you have shut down your website, and that you have discontinued promotion of your product until the FDA compliance issues are fully resolved. The response states that your firms are continuing to evaluate the use of 30 Good Vibrations units that you distributed to schools as part of a pilot study of the device and that you plan to establish procedures to bring your clinical studies of the device into compliance with 21 CFR parts 50, 54, 56, 812, and 820.
Your response is not adequate in that you have failed to provide FDA with documentation of corrective actions, including corrective actions related to the units you distributed to schools as part of a pilot study.
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. In addition, 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.
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 have taken. Include documentation of the corrective actions you. 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 CDR Nicole L. Wolanski, Chief, Cardiovascular & Neurological Devices Branch, Division of Enforcement B, 2098 Gaither Road, Rockville, Maryland 20850. If you have any questions about the content of this letter please contact CDR Wolanski at 240-276-0295 or FAX 240-276-0325.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facilities. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letterand 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 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.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and