Inspections, Compliance, Enforcement, and Criminal Investigations
Restorative Health Services, Inc. 30-May-06
Department of Health and Human Services
Public Health Service
New Orleans District
May 30, 2006
WARNING LETTER NO. 2006-NOL-08
Aaron J. Sorensen, President
Restorative Health Services, Inc.
311 18th Avenue North
Nashville, TN 37203
Dear Mr. Sorensen:
On January 23, 30, and 31, 2006, a U.S. Food and Drug Administration (FDA) investigator inspected your medical device manufacturing facility, located at 31118th Avenue North, Nashville, Tennessee. We are writing to you regarding serious regulatory problems involving the product known as a cranial orthosis. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 USC 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.
At the conclusion of the inspection, a Form FDA-483, List of Inspectional Observations was issued to you. We acknowledge receipt of the response to this list of observations, dated April 3, 2006. We address this response below, in relation to the noted violations.
This inspection revealed the cranial orthosis devices manufactured by your firm are adulterated within the meaning of Section 501(h) of the Act, 21 USC 351(h), as the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements for devices which are set forth in the Quality System (QS) regulation, as specified in Title 21, Code of Federal Regulations, Part 820 (21 CFR 820). Significant deviations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a).
For example, your firm does not have a corrective and preventive action (CAPA) procedure. Your April 3, 2006, response does not contain a CAPA procedure. A CAPA procedure must contain requirements for: (a) analyzing sources of quality data, including, but not limited to, processes, quality audit reports, concessions, quality records, service records, complaints, returned product, to identify existing and potential causes of nonconforming product, or other quality problems; (b) investigating the cause of nonconformities related to the product, processes, and the quality system; (c) identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems; (d) verifying or validating the corrective and preventive action to ensure such action is effective and does not adversely affect the finished device; (e) implementing and recording changes in methods or procedures needed to correct and prevent identified quality problems; (f) ensuring the information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; and, (g) submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.
2. Failure to develop, conduct, control, and monitor production processes to ensure a device conforms to its specifications, as required by 21 CFR 820.70(a).
For example, your firm has no documentation to show compliance with the QS regulation including production and process procedures. In your April 3, 2006 response, you submitted your firm's "Quality Program for Restorative Health Services Cranial Helmet Operations" (Quality Program). In section II of your Quality Program, "Operational Quality Procedure Plan" (Plan), you do not adequately include the requirement for documentation of the review, approval, and processing of your production process to ensure your device conforms to its specifications. The Plan states [redacted].The treating practitioner's review and approval, as well as the technician's processing, should be documented as part of the device history record (DHR), which represents the records containing the production history of a finished device. In addition, the Plan should establish procedures for changes to your production process, which should be reviewed and approved by an individual designated to review the adequacy of the change before implementation.
3. Failure to establish and maintain procedures for acceptance activities, as required by 21 CFR 820.80(a).
For example, your firm does not have any acceptance activity procedures for the components received from your suppliers. Section IV of your Quality Program, "Material Tracking," submitted in your response dated April 3, 2006, does not include the requirement to document the acceptance or rejection of the inspection of the cranial helmet materials received from your supplier to confirm the materials conform to your specified requirements. In addition, you do not include procedures to control nonconforming product for materials which are rejected because they do not conform to your specified requirements. Such procedures must address the identification, documentation, evaluation, segregation, and disposition of the nonconforming product.
4. 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, your firm does not have a design change procedure for any design changes made to your device. The design control requirements of 21 CFR 820.30 apply to designs established after June 1, 1997, when the QS regulation became effective. Your device appears to have been designed, manufactured, and distributed before the effective date of the QS regulation. However, your firm must establish a design change procedure to ensure changes are appropriate and the device will continue to perform as intended.
Your Quality Program, submitted in your April 3, 2006 response, does not include procedures for the identification, documentation, validation, or, where appropriate, verification, review, and approval of design changes before their implementation. When changes are made to your existing design, the design controls of 21 CFR 820.30 must be followed to ensure the changes are appropriate and the device will continue to perform as intended [61 Federal Register, 52602, (October 7,1996) (61FR), at 52616, Comment 64]. Generally, design controls require the following procedures to control the design of the device in order to ensure specified requirements are met: (a) design and development planning to describe the design and development activities; (b) design input to ensure the design requirements are appropriate and address the intended use of the device, including the needs of the user and patient; (c) design output to allow for an evaluation of conformance to design input requirements, contains or makes reference to acceptance criteria, and identifies those design outputs essential for the proper functioning of the device; (d) design review; and, (e) design validation or verification to confirm the design output meets the design input requirements. The results of the above design controls requirements, including the date and signature of the individuals approving the requirements, must be documented in the design history file (DHF), which comprises the compilation of records describing the design history of a finished device.
5. Failure to establish and maintain a quality system appropriate for the specific medical device being manufactured by your firm, as required by 21 CFR 820.5.
For example, your firm does not have a quality system meeting the requirements of the QS regulation. FDA notes the QS regulation provides a framework of basic requirements for manufacturers to establish a quality system appropriate to the devices designed and manufactured and the manufacturing processes employed [61 FR at 52605, Comment 3]. The extent of the documentation necessary to meet the regulation requirements may vary with the complexity of the design and manufacturing operations, the size of the firm, and the risk associated with the device [61 FR at 52607, Comment 13].
6. Failure to establish quality system procedures and instructions, as required by 21 CFR 820.20(e).
For example, your firm does not have quality system procedures and instructions.
7. Failure to establish a management representative with executive responsibility, as required by 21 CFR 820.20(b)(3).
For example, your firm does not have an appointed management representative who, irrespective of other responsibilities, has established authority over and responsibility for ensuring quality system requirements are effectively established and maintained, and reports on the performance of the quality system to management with executive responsibility for review. Your Quality Program, submitted in your April 3, 2006 response, does not designate a management representative with executive responsibility. This management representative must have authority over and responsibility for ensuring quality system requirements are effectively established and maintained, as well as reporting the performance of the quality system to management.
8. Failure to establish and maintain procedures for quality audits and to conduct such audits, as required by 21 CFR 820.22.
For example, your firm does not have procedures established for conducting quality audits to assure the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system.
9. Failure to establish a quality plan which defines how the requirements for quality will be met, as required by 21 CFR 820.20(d).
For example, your firm does not have a quality plan established which defines the quality practices, resources, and activities relevant to your device.
Our inspection also revealed your devices are misbranded under Section 502(t)(2) of the Act, 21 USC 352(t)(2), as your firm failed or refused to furnish material or information regarding the device, as required by or under section 519 of the Act, 21 USC 360i, and 21 CFR Part 803 - Medical Device Reporting (MDR) regulation. Significant violations 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 does not have an internal formal system for evaluating adverse events and submitting the required MDR reports to FDA. Your April 3, 2006, response does not include a written MDR procedure for evaluating adverse events and submitting the required MDR reports to FDA. Please refer to the March 1997 FDA document entitled "Medical Device Reporting for Manufacturers" for a discussion of the MDR requirements, including an overview of the required written MDR procedures, records, and files [See http://www.fda.gov/cdrh/manual/mdrman.pdf].
You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action being initiated by FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Federal agencies are advised of the issuance of all Warning Letters about devices so they may take this information into account when considering the award of contracts. Additionally, no premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will be approved until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be granted until the violations related to the subject devices have been corrected.
This letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483, issued at the closeout of the inspection may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by FDA. You must promptly initiate permanent corrective and preventive action on your quality system.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent recurrence of these or similar violations. Include all documentation of the corrective action you have taken. 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 the U.S. Food and Drug Administration, Attention: Nicole F. Hardin, Compliance Officer, at 2424 Edenborn Avenue, Suite 410, Metairie, Louisiana 70001. If you have any questions about the contents of this letter, please contact Ms. Hardin at (504) 219- 8818, extension 102.
Carol S. Sanchez
Acting District Director
New Orleans District