Ortho-Cycle Company Inc. 5/16/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
RETURN RECEIPT REQUESTED
May 16, 2013
Mr. Petre Cioara, President
Ortho-Cycle Company Inc.
2026 Scott Street
Hollywood, Florida 33020-2417
Dear Mr. Cioara:
During an inspection of your firm located in Hollywood, Florida March 11 – 13, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a reprocessor of single-use metal and ceramic dental brackets. 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.
The current inspection revealed 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, its 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. As a reprocessor of single-use devices you are considered to be a manufacturer, and as such, are subject to those requirements of the Quality System regulation that apply to the operations that you perform.
We received a written response from you on April 1, 2013, concerning our investigator’s observations cited on the Form FDA 483, List of Inspectional Observations. We address this response below, in relation to each of the noted violations. The violations include, but are not limited to the following:
1. Failure to adequately ensure, where the results of a process cannot be fully verified by subsequent inspection and test, that the process shall be validated with a high degree of assurance and approved according to established procedures. The validation activities and results, including the date and the signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented, as required by 21 CFR 820.75(a). For example, your firm failed to validate or provide adequate documentation of validation for the following processing steps used to reprocess single-use metal and ceramic dental brackets at your firm:
a. Your firm failed to perform any process validation related to the reprocessing of ceramic brackets, gold-plated brackets or expansion screws.
b. Your firm failed to validate the (b)(4) process used during the reprocessing of metal dental brackets.
c. Your firm failed to provide adequate documentation of validation for the (b)(4) Process used during the reprocessing of metal dental brackets. The documentation provided was inadequate as it did not include what percentage of (b)(4) was used, what specific (b)(4) or time was used, and it failed to document when multiple reprocessing sessions are used, or how many cycles the brackets can withstand.
d. Your firm failed to provide adequate documentation of validation for the (b)(4) Removing and Shining of Metal Attachments (b)(4) used during the reprocessing of metal dental brackets. Validation V-09 Rev. 5, dated 10/4/2011, provided by your firm was inadequate in that it failed to specify process time and (b)(4); amount of (b)(4) and (b)(4) used; number of samples inspected; worse case bracket included in the study; acceptance criteria regarding (b)(4); and no raw data was available to support testing performed.
We reviewed your firm’s response and conclude that it is not adequate. FDA acknowledges your intent to no longer reprocess ceramic dental brackets, gold-plated dental brackets, and expansion screws. Your compliance to this commitment will be verified during FDA's next scheduled inspection of your facility. The other corrective actions related to this observation appear to be on-going; therefore, the adequacy of those corrective actions cannot be determined at this time as the information provided appears to be incomplete. For example, your firm only provided a time frame for when the validation of the (b)(4) Process Validation and (b)(4) Removing and Shinning of Attachments processes will be completed, which is “approximately 60 days”. Additionally, you did not provide evidence that a systemic corrective action was considered, such as the review of other processes or tests performed during reprocessing to ensure that they were validated as required.
2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example:
a. Your firm’s complaint handling procedures and work instructions (QMP-013, Rev. 6 and WI-006, Rev. 6) are inadequate in that they lack requirements for complaint investigations for complaints where no product is returned to the firm and it does not include a requirement for timely processing of complaints.
b. A review of your firm’s complaint/return documentation for 2011, 2012, and 2013 indicates multiple complaints were received for malfunctions such as: gingival wings bent; lock doors not functioning well; spring damage on sliding doors; and loose doors. All reported malfunctions were not documented using the Consumer Complaint Report as required by your procedures and instructions. As for those complaints which were documented using report forms, the investigation documentation was not conclusive or complete. Specifically, Complaint#01-12, involving a consumer reporting “too many brackets with gingival brackets wings bent”, was missing information to include, how the bent occurred, did the customer receive the product damaged, was the bent a malfunction of the device, and who determined an investigation of this issue was not needed as the firm did not conduct any investigational activities for this complaint to confirm the extent of the damage and/or malfunction of the device.
c. A review of your firm’s complaint/return log for 2011, 2012, and 2013 also revealed 29 complaints that were described as “No explanation”. Your firm did not have evidence of any attempt to gain additional information for each of these complaints or document if the complaint involved a device failure.
We reviewed your response and conclude it is not adequate. In your response, you failed to provide detailed information or documentation that would assist us in evaluating whether you have implemented a corrective action. You also failed to provide evidence that a systemic corrective action was considered, such as a review of all complaint records to determine if the appropriate action was taken or if additional information is needed for your evaluation.
3. Failure to establish and maintain adequate procedures to ensure all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example, during the inspection you indicated that your firm failed to set specifications of incoming materials such as (b)(4) and (b)(4) used to fulfill processing parameters during the reprocessing of metal dental brackets by your firm. Additionally, your purchasing controls procedures are inadequate in that they state if the incoming materials are used in a production process and produce successful results, then the supplier is approved.
4. Failure to establish and maintain adequate procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). Specifically, your firm’s CAPA procedure QMP-016, Rev. 6 lacks a requirement that each CAPA be verified and/or validated as effective and that it does not adversely affect the finish device.
5. Failure to establish and maintain adequate process control procedures that describe any process controls necessary to ensure conformance to specifications where deviations from device specifications could occur as a result of the manufacturing process, as required by 21 CFR 820.70(a). Specifically, your firm failed to include documentation on the amount of (b)(4) used during (b)(4) and the concentration of (b)(4) used for (b)(4) in the Bracket and Bands Cleaning Work Instruction (WI-002, Rev. 5). During the inspection, you indicated cleaning is a necessary processing step for the reprocessing of metal dental brackets by your firm.
6. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. For example:
- Your procedures for quality audits fail to include all areas of the Quality System Regulation (QSR) that apply to your operations such as, process validation and complaint handling.
We reviewed your response the above violations, items 3, 4, 5, and 6 and conclude it is not adequate. In your response, you stated your firm needed 60 days for evaluation, yet you failed to provide detailed information or documentation that would assist us in evaluating whether you plan to implement corrective actions within the requested timeframe. You also failed to outline the specific steps you will take to establish and follow written procedures and policies designed to comply with the aforementioned violations.
Our inspection also revealed that your medical devices are misbranded under section 502(t)(2) of the Act (21 U.S.C. § 352(t)(2)) in that your firm failed or refused to furnish material or information respecting the device that as required by or under section 519 of the Act (21 U.S.C. § 360i) and 21 CFR Part 803 - Medical Device Reporting (MDR) regulation. Significant violations include but are not limited to, the following:
Failure to adequately develop, maintain and implement written MDR Procedures, as required by 21 CFR 803.17. For example, your firm’s complaint procedure and instructions include MDR requirements that fail to include the following:
a. The procedure and instructions do not establish internal systems that provide for timely and effective identification, communication, and evaluation of events which may be subject to MDR requirements. For example, there are no definitions of what is considered a reportable event under 21 CFR 803. To facilitate the correct interpretation of reportable events and to assure the quality of MDR submissions, the procedure should include definitions, based on 21 CFR 803.3, of the terms: “become aware,” “caused or contributed,” “malfunction,” and “MDR reportable event;” as well as, definitions of the terms “reasonably known” and “reasonably suggests,” found respectively in 21 CFR 803.50(b)and 21 CFR 803.20(c)(1).
b. The procedure and instructions do not establish internal systems which provide a standardized review process to determine when an event meets the criteria for reporting per 21 CFR 803. For example:
The procedure states the reporting of a complaint involving death or serious injury to competent authorities where the incident occurred, FDA and Notified body no later than (b)(4) days from the initial receipt of the information. However, there are no instructions for conducting an investigation of each event and evaluating the cause of the event, as required by 21 CFR 803.50(b)(3).
The procedure does not specify who makes the decision for reporting events to FDA.
c. Your MDR procedure does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
- Instructions for how to obtain and complete the FDA Form 3500A;
- Instructions for how you will submit all information reasonably known for each event;
- Circumstances under which you must submit initial, supplemental, or follow-up reports and the requirements for such reports; and,
- The address for where to submit MDR reports: FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002.
We reviewed your firm’s response and conclude that it is not adequate. FDA acknowledges receipt of your updated procedure, SOP-02: Standard Operating Procedure, Medical Device Reporting; however this procedure fails to fulfill all requirements of Medical Device Reporting, as required by 21 CFR 803.17. For example, you procedure does not specify who makes the decision for reporting events to FDA, instruct how you will perform an MDR investigation , instruct how you will submit all reasonably known information for each event, and does not outline the circumstances under which you must submit initial, supplemental, or follow-up reports. Additionally, your definition for “become aware” is a repeat of the timeframe in which you must submit a MDR report to FDA and not how your firm will define “Day 1” to comply with the 30-day reporting requirement.
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 Class III devices to which the Quality System regulation violations 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 device have been corrected.
Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps you have taken to correct the noted violations, as well as an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions you have taken. If your planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of these activities. If corrections and/or corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed. Your response should be comprehensive and address all violations included in this letter.
Your response should be sent to: Erica M. Katherine, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions about the content of this letter please contact: Erica M. Katherine at (407) 475-4731.
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 on the Form FDA 483, Inspectional Observations (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management 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.
Emma R. Singleton