Inspections, Compliance, Enforcement, and Criminal Investigations
Frye Health Systems, Inc. 31-Aug-06
Department of Health and Human Services
Public Health Service
August 31, 2006
RETURNED RECEIPT REQUESTED
Dr. Bruce A. Frye, D.C., and Owner
Frye Health Systems, Inc.
3227 South Lakewood
Tulsa, OK 74135
Dear Dr. Frye:
During an inspection of your firm located in Tulsa, Oklahoma on July 17 through July 19, 2006, the United States Food and Drug Administration (FDA) determined that your firm manufactures the Frye Adjusting Instrument, a chiropractic device that is indicated for chiropractic adjustment of the spine and extremities. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act- (the Act) (21 U.S.C. § 321(h)), these products are 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 these devices are 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 conformance 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.
At the close of the inspection, FDA issued to you a List of Inspectional Observations, Form FDA-483, which identifies a number of significant violations. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and documented, and address the intended use of the device, including the needs of the user and patient, as required by 21 CFR § 820.30(c). Your firm failed to identify, approve, and document appropriate design inputs prior to the start of its formal design of the Frye Adjusting Instrument. For example:
a. On July 17, 2006, during the inspection, you presented a one page and undated document entitled "Design Input" to the FDA investigator for review. Your firm referenced multiple terms of "design inputs" throughout this document without documenting your specific design inputs (e.g. specific physical and performance requirements of the device). Your firm's 510(k) summary posted on the FDA's website documented that your device was designed to offer easier use to those chiropractors that have limited strength or dexterity in their hands and the device was indicated for chiropractic adjustment of the spine and extremities. Statements relating to the user needs and the device's intended use were not documented in your "Design Input" document.
b. Later on July 18, 2006, during the inspection, you revised the "Design Input" document to list some specific device design specifications and presented this revised document to the FDA investigator for review. Your July 18, 2006 "Design Input" document documented incomplete, ambiguous, unclear or conflicting device design specifications. For example, you documented a minimum force of [redacted] and a maximum force of [redacted] for the device's force output. The [redacted] maximum force is not documented in your final product testing and exceeds a maximum force specification of [redacted] you verbally stated to the FDA investigator during your demonstration of the final product testing. Additionally, your verbal acceptance specification of [redacted] to [redacted] used during the final product testing is not documented.
c. Your July 98, 2006 "Design Input" document recommended using pneumatic power as a source of pressurized air without defining and documenting an approved minimum and maximum air pressure output specification from an air compressor recommended for use with your device. Your revised "Design Input" document further described "the instrument should have a physical requirement of a sufficient weight . ..the instrument body be made of aluminum and of sufficient size to absorb recoil" without defining and documenting a quantitative value for the weight and specific dimensional specifications for the device.
2. Failure to establish and maintain procedures for validating the device design to ensure that the device conforms to user needs and intended uses and to include design testing under actual or simulated use conditions and risk analysis, and failure to document the results of the device design validation, as required by 21 CFR § 820.30(g). For example:
a . Your firm failed to adequately identify and document all possible risks associated with your device and document the results of your firm's risk analysis. Your undated and unsigned study proposal entitled "Part 1: Proposal" stated that "the hazard risk would include the force too extreme for a safe adjustment and measuring the force of the predicate device, and setting the Air Activator to those standards to mitigate this risk." Your firm failed to define the specific maximum force output and design features or to reference specific recognized standards to prevent the device's force output from exceeding your approved maximum specification. Additionally, your firm claimed to have measured the predicate device's force output but failed to document the results of your measurements. Your firm also failed to identify, explain, and document other risk controls such as warnings and user instructions or training.
b. In your summary of major pre-clinical and clinical activities (Part 1: Proposal), you failed to maintain documentation of the user testing results in order to prove that your study proposal had been conducted.
3. Failure to establish and maintain complaint handling procedures for receiving, reviewing, evaluating, and documenting complaints by a formally designated unit, as required by 21 CFR § 820.198(a). For example:
a. Your firm failed to establish any written complaint handling procedures to handle its receipt and evaluation of potential complaints received from end users or your distributor.
b. Your firm failed to document its receipt of oral complaints,or user reports of product issues.
c. Your firm maintained e-mails of complaints, but it has not evaluated these e-mails to determine if they are considered valid complaints and documented your firm's evaluation of each complaint.
4. Failure to establish and maintain adequate procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria prior to releasing the devices for distribution, as required by 21 CFR § 820.80(d), and failure to maintain adequate acceptance records, as required by 21 CFR § 820.80(e). For example:
a. You stated that the final product testing consisted of measuring the torque and force of each device when connected to a controlled air compressor but that your firm had no written testing procedures, including specific acceptance criteria or test methods.
b. Your firm failed to document the results of the final testing for each device.
5. Failure to maintain device master records (DMR) to include, or refer to the location of, device specifications, production process specifications, quality assurance procedures, and packaging and labeling specifications, and to ensure that each DMR is prepared and approved in accordance with 21 CFR § 820.40, as required by 21 CFR § 820.181. For example:
a. You stated that your firm added product literature, user instructions, and warranty flyer and then packaged each device prior to shipping. Your firm failed to establish written procedures for its device labeling and packaging activities, including labeling inspection.
6. Failure to maintain service reports for serviced devices, as required by 21 CFR § 820.200(d). For example, your firm failed to maintain service reports for each device returned to your firm for servicing or repair (e.g. the name of the device, the date of service, the individual(s) servicing the device, the service performed, and the test and inspection data).
7. Failure to establish, maintain, and document procedures for implementing corrective and preventive action, as required by 21 CFR § 820.100(a). For example:
a. Your firm had no written procedures for implementing corrective and preventive action.
b. Your firm failed to document the results of its analysis or evaluation of emails of complaints and service reports in order to identify existing and potential causes of nonconforming product. You stated that you mentally evaluated complaints and servicing or repairs of returned devices but that you had not documented any evaluations.
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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil 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 OS 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 these corrections. If the 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 Thao Ta, Compliance Officer, DAL-DO, Food and Drug Administration, HFR-SW140, 4040 N. Central Expressway, Suite 300, Dallas, TX 75240. If you have any questions about the contents of this letter, please contact Mr. Ta at 214-253-5217.
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 Form 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.
Michael A. Chappell
Dallas District Director