RMO, Inc. 11/10/11
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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
November 10, 2011
Mr. Antoun H. Zakhem
Chairman and CEO
650 W. Colfax Ave.
Denver, CO 80204
Ref # DEN-12-04-WL
Dear Mr. Zakhem:
During an inspection of your firm located at 650 West Colfax, Avenue, Denver, Colorado, on August 22 – 26, 2011, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures Class II orthodontic plastic brackets and repackages/relabels Class II dental adhesives, headgear, resins and impression material. 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 (CFR), 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 validate with a high degree of assurance, a process where the results cannot be fully verified by subsequent inspection and test as required by 21 CFR 820.75(a).
Specifically, you have no documentation that the injection molding process for Miura Plastic Brackets, using the (b)(4) injection molding machine has been validated. In addition, you have no documentation that the packaging and labeling process for the Miura Plastic Brackets has been validated. This deviation was previously noted during our January 28 – February 2, 2009 inspection and reported to you on Form FDA 483, Inspectional Observations, dated February 2, 2009.
2. You have failed to establish and maintain procedures for implementing corrective and preventive actions, which include verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, as required by your Corrective and Preventive Action procedure, QMP017 and 21 CFR 820.100(a)(4).
• (b)(4) Engineering Service Requests (ESR) we reviewed had not been verified for effectiveness and;
• (b)(4) Material Review Board (MRB) actions we reviewed contained no documentation that corrective actions had been implemented.
3. You have failed to establish and maintain procedures for acceptance activities which include inspections, tests, or other verification activities, as required by your Mold/Trim Operations for Polycarbonate Brackets procedure, QIS 726-090075 and 21 CFR 820.80(a).
• In-process inspection results conducted during the molding and trimming operation of the Miura Plastic Brackets were not documented on (b)(4) Data Sheets reviewed, (21 CFR 820.80(c));
• In-coming acceptance procedures have not been established for partially pre-labeled poly bags, (b)(4), used in the production of Miura Plastic Brackets, (21 CFR 820.80(b)).
4. You have failed to establish and maintain procedures to ensure that adequate sampling methods are utilized as required by your Mold/Trim Operations for Polycarbonate Brackets procedure, QIS 726-090075, Packaging Inspection – Distribution procedure, QIS 726-00138 and 21 CFR 820.250(b).
• Your sampling plan, QIS 726-090075, for molding in-process inspection and trimming in-process inspection of Miura Plastic Brackets was not followed for (b)(4) Data Sheets (lots) reviewed.
• Your sampling plan, QIS 726-00138, for packaged Miura Plastic Brackets was not followed for (b)(4) Data Sheets (lots) reviewed.
5. You have failed to establish and maintain procedures to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, and to document the evaluation, as required by your Initial Vendor Qualification procedure, WIPR001, and 21 CFR 820.50(a)(1).
Specifically, you have no documentation that your suppliers of the components, resin and poly bags, were evaluated for their ability to meet specified requirements.
6. You have failed to maintain device master records (DMR) that contain or refer to the location of device specifications as required by 21 CFR 181. Specifically, your DMR for Miura Plastic Brackets does not contain or refer to labeling specifications. This deviation was previously noted during our January 28 – February 2, 2009 inspection and reported to you on Form FDA 483, Inspectional Observations, dated February 2, 2009.
7. You have failed to establish and maintain device history records (DHR) for Miura Plastic Brackets that contain or refer to the primary identification label and labeling used for each production unit as required by 21 CFR 820.184(e). Specifically, (b)(4) DHRs reviewed for Miura Plastic Brackets did not contain or refer to the primary identification label or labeling.
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: U.S. Food and Drug Administration, Denver District, P.O. Box 25087, (6th Avenue and Kipling Street, 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