- R&D Engineering Of Earlham Inc
- Issuing Office:
- Kansas City District Office
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Kansas City District|
8050 Marshall Drive, Suite 205
Lenexa, Kansas 66214
Telephone: (913) 495-5100
May 16, 2014
Ref: CMS # 429995
Rodney M. Ramsey, President
R&D Engineering of Earlham, Inc.
690 N. Chestnut Avenue
Earlham, Iowa 50072
Dear Mr. Ramsey:
On April 17 through May 1, 2014 United States Food and Drug Administration (FDA) investigators conducted an inspection of your facility located at 690 N. Chestnut Avenue in Earlham, Iowa 50072. During this inspection, our investigators documented significant deviations from the current good manufacturing practice regulations for medical devices, Title 21 Code of Federal Regulations, Part 820 (21 CFR Part 820). The suction canister and lid, and kidney transport tray, your firm manufactures are considered to be medical devices within the meaning of Section 201(h) [21 U.S.C. 321(h)] of the Food, Drug, and Cosmetic Act (the Act) and the deviations from current good manufacturing practice regulations observed during the inspection render medical devices manufactured at your facility adulterated within the meaning of Section 501(h) [21 U.S.C. 351(h)] of the Act. You can find the Act and its implementing regulations from links on FDA's homepage at www.fda.gov.
Section 501(h) of the Act states "A device shall be deemed adulterated - If it is a device and the methods used in, or the facilities used for, its manufacture, packaging, storage or installation are not in conformity with applicable requirements under section 520(f)(1) or an applicable condition prescribed by an order under 520(f)(2)".
Your firm lacks Quality System procedures and instructions, as required by 21 CFR 820.20(e). The deviations from current good manufacturing practice regulations observed during the inspection are a result of your firm's lack of Quatity System procedures and instructions. Specific examples of deviations include, but are not limited to, the following:
1. Failure to ensure the presence of identification labels on each suction canister and lid, and on each kidney transport tray, as required by 21 CFR 820.60. Although your firm places a "serial number" on the outside of each cardboard box the medical devices are packaged in, once the device is removed from the cardboard box, you no longer have any way to link the device to even this number.
2. Failure to establish Device Master Records and Device History Records containing the required information for both the suction canister and lid, and the kidney transport tray, as required by 21 CFR 820.181 (Device Master Records) and 21 CFR 820.184 (Device History Records). While your firm has a Device Master Record for the suction canister and lid, it lacks certain required information such as, but not limited to, updated drawings, quality assurance procedures and specifications including acceptance criteria, and label specifications. The production sheet which your firm recently began using as a Device History Record for the suction canister and lid fails to contain the required information such as, but not limited to, the primary identification label, and specifications and testing data to ensure the device meets specifications. Your firm has neither a Device Master Record nor a Device History Record for the kidney transport trays.
3. Failure to establish acceptance activities for receiving incoming raw materials used in the manufacture of the suction canister and lid, and kidney transport tray, as required by 21 CFR 820.80(b). Your firm has no testing activities or procedures for testing and evaluating raw materials and no acceptance criteria for raw materials.
4. Failure to establish acceptance activities for the in-process and finished suction canister and lid, and kidney transport tray, as required by 21 CFR 820. 80(c) (in-process device) and 21 CFR 820.80(d) (finished device). Your firm has no testing activities or procedures for testing and evaluating in-process and finished devices and no acceptance criteria for in-process and finished devices.
5. Failure to document evaluation or quality requirements of suppliers or vendors, as required by 21 CFR 820.50(a). Your firm has not evaluated your suppliers' ability to provide materials of adequate quality used to manufacture medical devices such as suction canisters and lids, and kidney transport trays. Further, your firm has no quality agreements in place with your suppliers or vendors.
6. Failure to ensure manufacturing equipment is calibrated, as required by 21 CFR 820.72(b). Your firm has failed to calibrate the scale used in the production of your firm's medical devices such as the suction canisters and lid s, and the kidney transport trays.
Your firm 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 civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen (15) business days, state the reason for the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address all violations included in this Warning Letter.
Your firm's response should be sent to: Amy E. Devine, Compliance Officer, U.S. Food and Drug Administration, Kansas City District, 8050 Marshall Drive, Lenexa, Kansas 66214-1524.
Refer to CMS # 429995 when replying. If you have any questions about the contents of this letter, please contact Compliance Officer Devine at (913) 495-5147.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm's facility. It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Ann M. Adams
Acting District Director
Kansas City District