ASI Medical, Inc. 4/20/11
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
April 20, 2011
Mr. John W. McPeek
ASI Medical, Inc.
14550 E. Easter Ave., Suite 700
Englewood, CO 80112
Ref # DEN-11-10 WL
Dear Mr. McPeek:
During an inspection of your firm located at 14550 E. Easter Avenue, Centennial, Colorado, on November 29, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures dental operative units. 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 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. You can find these regulations on the FDA website at www.fda.gov
Significant deviations include, but are not limited to, the following:
1. You have failed to follow your firm’s QS Standard Operating System Procedures (SOP) in the following required areas:
• You have not maintained complaint files, documented complaint investigations, or Medical Device Reporting (MDR) evaluations, as required by your (b)(4), Customer Service Contact/Complaint Handling, (b)(4), (21 CFR 820.198). A limited review of your complaint log revealed five complaints that had not been fully documented or evaluated.
• You have not followed your procedure to control product that does not conform to specified requirements, SOP (b)(4), Nonconforming Items & Corrective Action, (b)(4), (21 CFR 820.90(a)). No Quality Control Exception Reports have been created as of the date of this inspection, although two defective units were noted in the production area.
• You have not followed your SOP (b)(4), Corrective Action and Follow-Up, (b)(4), (21 CFR 820.100(a)(1)). Although two corrective actions were noted during the inspection, to date, you have not prepared any Corrective Action Request forms which are required to initiate corrective actions.
• You have not followed your SOP (b)(4), Final QC & Finished Product, (b)(4)(b)(4), that requires the device history record include a test certificate for (b)(4)(b)(4),” (21 CFR 8020.80(d)). Specifically, it was noted that your firm has not conducted the (b)(4) testing since December 2008.
• You have not followed your SOP (b)(4), Receiving, Inspection & Stocking of Parts & Materials, (b)(4) which states that incoming shipments will be inspected for conformance to specifications and reported on the Receiving and Inspection Report, (21 CFR 820.80(b)). Specifically, your firm does not document the acceptance of incoming products.
• You have not conducted any management reviews of the quality system as required by your SOP (b)(4), Management Responsibility, Reviews and Quality System, (b)(4), (21 CFR 820.20(c)).
• You have not conducted any quality audits as required by your SOP (b)(4), Quality Assurance Audits, (b)(4), (21 CFR 820.22).
• You have not followed your SOP (b)(4), Engineering Change/Document Change Control, (b)(4), which requires Engineering Change Notice (ECN) forms be completed to order a design change and begin implementation, (21 CFR 820.30(i)). During the inspection it was noted that (b)(4) design changes were made to your advanced dental operative units without authorization by ECNs.
• You have not implemented your SOP MP (b)(4), Vendor Selection, Files and Inspections, dated (b)(4), which requires documentation of the evaluation and approval of vendors, including the establishment of an approved vendor list, (21 CFR 820.50).
2. You have failed to maintain device master records (DMR) for your dental operative units that contain or refer to the location of:
• Device specifications;
• Production process specifications;
• Quality assurance procedures; and
• Packaging and labeling specifications, (21 CFR 181).
3. You have failed to establish and maintain a design history file (DHF) for each type of device you manufacturer that contains software. Specifically, the self-contained Triton models, the Classic Umbilical models, and the Designer Umbilical models. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of 21 CFR 820, (21 CFR 820.30(j)).
We acknowledge receipt of your December 20, 2010 and February 25, 2011 letters responding to our Inspectional Observations, Form FDA 483 dated November 29, 2010. Your response is inadequate in that although you reported making corrections in some areas where deficiencies were noted, you did not provide any documentation of these corrective actions. Your corrective actions will be fully evaluated during our next inspection.
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 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 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 any additional 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 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.
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, 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.
Your response should be sent to: Food and Drug Administration, Denver District, P. O. Box 25087, (6th Ave. and Kipling Pkwy., DFC, Bldg 20), Denver, CO 80225-0087, Attention: William H. Sherer, Compliance Officer. If you have any questions, please contact Mr. Sherer at (303) 236-3051.
LaTonya M. Mitchell
Acting District Director