Inspections, Compliance, Enforcement, and Criminal Investigations
Assistive Technology, Inc. 21-Mar-05
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
March 21, 2005
Mr. Thomas E. Roberts
Assistive Technology, Inc.
21279 Protecta Drive
Elkhart, IN 46516-9539
Dear Mr. Roberts:
During an inspection of your establishment located in Elkhart, Indiana conducted on January 18-25, 2005, the United States Food and Drug Administration (FDA) determined that your establishment manufactures the TEMPS bed (a knock-down patient gurney), as well as other patient transport and transfer products . These products are Class 1 or Class 2 medical devices as defined by Section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act). The purpose of the inspection was to evaluate the adequacy of your activities related to the manufacturing of finished medical devices.
The above-referenced inspection revealed. that these devices are adulterated within the meaning of Section 501(h) of the Act, 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 requirements of the Quality System Regulation (QS regulation), as specified in Title 21, Code of Federal Regulations (CFR), Part 820. The FDA investigator observed significant deviations including, but not limited to, the following:
Your firm failed to establish a Quality System, as required by 21 CFR 820.5. [See, for example, FDA-483 observation 1. A.].
Your firm failed to comply"with the Quality System Management Responsibility requirements of 21 CFR 820:20(a)-(e). [See, for example, FDA-483 observations 1.B, C, D, E and G; and 2.].
Your firm failed to establish effective procedures for or to conduct quality audits, as required by 21 CFR 820.22. [See, for example, FDA-483 observations 1.F. and 3.B.).
Your firm failed to establish procedures for and to conduct training of your employees, as required by 21 CFR 820.25 . [See, for example, FDA-483 observation 3.M.].
Your firm failed to establish procedures for and to perform the elements of design control for your TEMPS bed patient gurney product, a Class 2 medical device, as required by 21 CFR 820.30. [See, for example, FDA-483 observation 5].
Your firm failed to establish and follow effective document approval, distribution and change procedures, as required by 21 CFR 820.40 [See, for example, FDA-483 observations 11, 12, and 14.].
Your firm failed to establish and follow effective purchasing control procedures, as required by 21 CFR 820.50 [See, for example, FDA-483 observations 3.J. and 7.].
Your firm failed to establish procedures for receiving, in-process and finished device acceptance activities, and to conduct a review of the Device History Records and associated quality system records, as required by the 21 CFR 820.80(a) - (e). [See, for example, FDA-483 observations 3.1. and 6. and 16.A.].
- Your firm failed to ensure that packaging and shipping containers are designed and constructed to protect the devices during customary conditions of storage, handling and distribution, as required by 21 CFR 820.130. [See, for example, FDA-083 observation 15]. Your firm failed to retain for a period of at least two years from the date of release for distribution, the records required by the Quality System Regulation, as required by 21 CFR 820.180(b). [See, for example, FDA-483 observation 10].
- Your firm failed to maintain complete Device Master Records (DMR) to include all the elements required by 21 CFR 820.181 . [See, for example, FDA-483 observations 3.L. and 12.] .
- Your firm failed to establish and maintain procedures to ensure that Device History Records (DHR) demonstrate that devices are manufactured according to the Device Master Records, as required by 21 CFR 820.184. [See, for example, FDA-483 observation 9.].
- Your firm failed to establish procedures for the receipt, review and evaluation of product complaints as required by 21 CFR 820.198. In addition you failed to establish a procedure for preparation and submission of Medical Device Reports (MDR) as required by 21 CFR 803.17 concerning any complaints found to be reportable, as required by 21 CFR 820 .198(a)(3) . (See, for example, FDA-483 observations 3.G. and 4.].
This letter is not intended to be an all inclusive list of deficiencies at your facility. It is your responsibility to assure adherence to each requirement of the Act and regulations. Other Federal agencies are advised of the issuance of all Warning Letters about medical devices so that they may take this information into account when considering the award of contracts.
You should take prompt action to correct these violations . Failure to promptly correct violations may result in enforcement action being initiated by the FDA without further
notice . These actions include, but are not limited to seizure, injunction and civil penalties. Additionally, pending 510(k) or PMA applications and export approval requests may not be approved until the violations are corrected.
Please notify this office in writing, within fifteen (15) working days of your receipt of this letter, as to the specific steps you have taken to correct the noted violations, including (1) the time frames within which the corrections will be completed, (2) any documentation indicating the corrections have been achieved, and (3) an explanation of
each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not occur.
Your reply should be directed to Melvin O. Robinson, Compliance Officer, at the above address.
Joann M. Givens