Inspections, Compliance, Enforcement, and Criminal Investigations
ElderTech Solutions, LLC 29-Jul-05
Department of Health and Human Services
Public Health Service
July 29, 2005
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 05-27
Patricia M. Banks, Manager
E1derTech Solutions, LLC
1815 114h Avenue NE
Bellevue, WA 98004
Dear Ms. Banks:
On June 2-3, 13, 2005, Food and Drug Administration (FDA) investigators conducted an inspection of your establishment located at 1815 114th Avenue NE, Bellevue, Washington. FDA has determined that your establishment markets the D-Rail Mobility System, which is a medical device under section 201(h) [21 U.S.C. 321(h)] of the Federal Food, Drug, and Cosmetic Act (the Act). We acknowledge the receipt of your response dated June 30, 2005. Your response only provided future dates in which you will have documents completed.
Our inspection 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 manufacturing, packing, storage, or installation are not in conformance with the current Good Manufacturing Practice (cGMP) requirements for medical devices which are set forth in the Quality System Regulation (QSR), as specified in Title 21, Code of Federal Regulations (CFR), Part 820, as follows:
1. Failure to establish quality system procedures and instructions,s as required by 21 CFR 820.20(e). To date, you had a contract manufacturer produce [redacted] sets of the D-Rail Mobility system for you with no procedures in place. You have distributed [redacted] of these sets to one customer. You showed our investigators a draft Quality System Manual, but you had not completed, approved, or implemented the manual.
2. 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). You did not establish design change procedures when you changed the D-Rail Mobility System in February/March 2005. Our investigators noted two emails in your records dated March 2, 2005, and May 27, 2005, in which the contract manufacturer discussed making a design change to the device. The change you made was to [redacted].
3. Failure to establish and maintain procedures to control the design of the device in order to ensure that specific design requirements are met, as required by 21 CFR 820.30(a). You have not established procedures for controlling the design of the D-Rail Mobility System. Also, you have failed to establish and maintain plans that describe or reference the design development activities and define responsibility for implementation, as required by 21 CFR 820.30(b). You did not establish a design and development plan for the D-Rail Mobility System, including defining responsibility, describing the interfaces with different groups or activities that provide or result in input to the design. You had no reviews, updates, or approvals of the design of the D-Rail Mobility System as it was being developed by your company, produced by your contract manufacturer, marketed by your company, or when you distributed [redacted] sets of the device.
4. Failure to document corrective and preventive action activities, as required by 21 CFR 820.100(b). Our investigators found you had two Corrective Action Reports dated February 7, 2005, and March 2, 2005, in which you implemented corrections to the D-Rail Mobility System device. You did not document the corrections or prevention activities associated with these reports.
5. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. You have a contract with a manufacturer to produce the D-Rail Mobility System device for you, and there is no documentation of the quality requirements you require of this manufacturer. This manufacturer produced this device in October 2004 for you under a contract.
6. Failure to establish and maintain data that clearly describes or references the specified requirements, including quality requirements, for purchased or otherwise received products or services, as required by 21 CFR 820.50(b). You have no purchasing documents that include there is an agreement between you and the contract manufacturer that you will be notified of any changes made to the device.
7. Failure to establish and maintain procedures for acceptance activities such as inspections, tests, or other verification activities, as required by 21 CFR 820.80(a). You have not established acceptance activities for the D-Rail Mobility System devices that you have had manufactured by your contract manufacturer, and for those you have distributed.
8. Failure to establish procedures for receiving, reviewing, and evaluating complaints, as required by 21 CFR 82o.198(a). You have not established a procedure for handling complaints even though your contract manufacturer has produced the D-Rail Mobility System for you, and you have distributed [redacted] sets of this device.
9. Failure to maintain a device master record that refers to the location of all production process specifications, including the appropriate equipment specifications, production methods, production procedures, and production environment specifications, as required by 21 CFR 820.181(b). The device master record you use for the D-Rail Mobility System does not include all of the production and process specifications. You were not able to provide any documentation for the manufacturing process of this device to our investigators. Also, you implemented a change to the design of the [redacted] and there was no documentation such as drawings or specifications, for the change.
10. Failure to have a management representative with established authority and responsibility for ensuring that quality systems are established, and who reports to management with responsibility for review, as required by 21 CFR 820.20(b)(3). You have not appointed a management representative to perform these functions.
11. Failure to have management review of the suitability and effectiveness of the quality system, as required by 21 CFR 820.20(c). You have not established a management review procedure or documented a review meeting, but you have manufactured and distributed the device.
This letter is not intended to be an all-inclusive list of 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.
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. Also, no requests for Certificates for Products for Export will be approved until the violations related to the subject devices have been corrected.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations 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.
Please notify this office within 15 working days of 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 identify and make corrections to any underlying system problems necessary to ensure that similar violations will not recur. Please include any and all documentation to show that adequate correction has been achieved. In the case of future corrections, an estimated date of completion, and documentation showing plans for correction should be included with your response to this letter.
Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Lisa M. Elrand at (425) 483-4913.
Charles M. Breen