Inspections, Compliance, Enforcement, and Criminal Investigations
DavisMade, Inc. 08-Aug-08
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
August 8, 2008
Daniel W. Davis
Founder and Owner
2511 Davison Road
Flint, MI 48506
Dear Mr. Davis:
During an inspection of your firm located in Flint, Michigan on March 12 through March 26, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures Standing Dani, Sprout, and Kidster Dani wheel-stand/wheelchairs, multi-positioning devices for physically handicapped children. 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 50l(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. 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 C.F.R. 820.30.
a. There are no established design control procedures which address the requirements for Design Input, Design Output, Design Review, Design Verification, Design Validation, Design Transfer or Design Changes.
b. The design history file for the Kidster Dani does not include the records necessary to demonstrate that the device was developed in accordance with an approved design plan and per the design control requirements.
2. Failure to establish and maintain procedures for implementing corrective and preventive actions (CAPA), as required by 21 C.F.R. 820.100(a).
For example, your firm has no established CAPA procedures describing the following: (a) analyzing processes, work operations, quality audits, service records, and returns; (b) investigating the cause of nonconformities and identifying the actions needed to correct and prevent recurrences; (c) verifying or validating corrective actions; (d) implementing changes; and (e) ensuring the information related to the non-conformities is disseminated to the correct individuals.
3. Failure to establish and maintain procedures for receiving, reviewing and evaluating complaints by a formally designated unit, as required by 21 C.F.R. 820.198(a).
For example, your firm has no established procedures for receiving, reviewing and evaluating complaints to ensure that: (a) all complaints are processed in a timely manner; (b) oral complaints are documented; and (c) complaints are evaluated to determine whether the complaint represents an event required to be reported to the FDA.
4. Failure to establish and maintain procedures to control product that does not conform to specified requirements; as required by 21 C.F.R. 820.90(a).
For example, base frames used in the manufacture of the Standing Dani, Sprout and Kidster Dani devices have on occasion not met acceptance criteria, but are not documented as non-conforming products.
5. Failure to establish and maintain procedures for acceptance activities, as required by 21 C.F.R. 820.80.
For example there are no procedures for receiving, in-process and finished device acceptance for the Standing Dani, Sprout and Kidster Dani devices.
6. Failure to establish and maintain purchasing data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services, as required by 21 C.F.R. 820.50(b).
For example. there are no written agreements with your contract manufacturers which require them to notify your firm of any changes in the products or services.
7. Failure to establish and maintain instructions and procedures for servicing, as required by 21 C.F.R. 820.200(a).
For example, your firm has no servicing procedures for the Standing Dani, Sprout, and Kidster Dani.
8. Failure to maintain Device Master Records (DMR's), which are to include or refer to: (a) the location of device specifications; (b) production and process specifications; (c) quality assurance procedures; (d) packaging and labeling specifications; and (e) installation, maintenance, and servicing procedures, as required by 21 C.F.R. 820.181.
For example, DMR's are incomplete for the Standing Dani, Sprout, and the Kidster Dani wheel-stand/wheelchair devices.
9. Failure to establish and maintain procedures to ensure that device history records (DHR's) for each batch, lot; or unit are maintained to demonstrate that the devices are manufactured in accordance with the device master record (DMR) and the quality system regulations, as required by 21 C.F.R. 820.184.
For example, DHR's are incomplete for the Standing Dani, Sprout, and Kidster Dani wheel-stand/wheelchair devices.
10. Failure to establish procedures for quality audits and to conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22.
For example, there is no documentation that quality audits have been conducted since 1995.
11. Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25.
For example, no formal training relating to the Quality System regulations has been provided.
12. Failure to ensure that an adequate quality system has been fully implemented and maintained at all levels of your organization, as required by 21 C.F.R. 820.20.
a. Management with executive responsibility has not appointed a management representative.
b. Your firm has no procedures defining management reviews and no documentation to show that management reviews of the suitability and effectiveness of the quality system have been conducted.
Our inspection also revealed that the Powered Standing Dani 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 by or under section 519 of the Act, 21 U.S.C. 360i, and 21 C.F.R. Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include; but are not limited to, the following:
1. Failure to develop, maintain, and implement a procedure for preparation and submission of Medical Device Reports (MDR's), as required by 21 C.F.R. 803.17. For example, your firm has no procedures for the following requirements:
a. Internal systems that provide for: (1) timely and effective identification, communication and evaluation of events that may be subject to MDR requirements; (2) a standardized review process or procedure for determining when an event meets the criteria for reporting to FDA; and (3) timely transmission of completed medical device reports to the FDA.
b. Documentation and record keeping requirements for: (1) information that was evaluated to determine if an event was reportable; (2) all medical device reports and information submitted to FDA; (3) any information that was evaluated for the purpose of preparing and submission of annual reports; and (4) systems that ensure access to the information that facilitates timely follow-up and inspection by FDA.
2. Failure to submit an MDR report within 30 days of receiving or otherwise becoming aware of information that reasonably suggest that a marketed device may have malfunctioned and would likely cause or contribute to a death or serious injury if the malfunction were to recur, as required by 21 C.F.R. 803.50(a)(2). For example, your firm failed to report a complaint dated June 22, 2006, involving the Powered Standing Dani with Head Control, serial number 001069, that documented an incident where the wheelchair tipped over while in use, and the child sustained injury which required a visit to an emergency department for evaluation. This event was not reported to the FDA as an MDR
Our inspection also revealed that the Rigid Manual Standing Dani, Rigid Powered Standing Dani, Tilt Manual Sprout, Rigid Manual Sprout, Rigid Powered Sprout, Tilt Manual Kidster Dani, Rigid Manual Kidster Dani, and the Rigid Powered Kidster Dani devices are 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.
The devices are 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 these devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k), and 21 CFR 807.81(a)(3)(i).
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 kinds of information you need to submit in order to obtain approval or clearance for your devices are described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.htm1. The FDA will evaluate the information you submit and decide whether your products maybe legally marketed.
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) 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 violation(s), or similar violation(s), 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 Judith A. Putz, Compliance Officer, at the above address.
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 maybe 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.
Joann M. Givens
Detroit District Office