February 15, 2013 -- WARNING LETTER
UPS OVERNIGHT MAIL
Hector Mark Estrada
Owner and President
Rigid FX Orthopedics, Inc.
12600 Hill Country Blvd., Suite R275
Austin, Texas 78734
During an inspection of your firm located in Austin, Texas, on August 27 through 29, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm (a specification developer) manufactures Clearview Wrist Fixation System TM for the treatment of distal radius fractures. 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 to affect the structure or any 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:
During the inspection, you promised corrective action and that your firm will provide a written response to the inspectional observations. As of November 2, 2012, we have not received your written response.
Quality System (QS) Regulation
1. Failure to establish and maintain adequate procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a).
Specifically, your firm has not established design control procedures for the Clearview Wrist Fixation System TM that include a design plan, design inputs, design outputs, design reviews, design verification, design validation, and design changes.
2. Failure to adequately ensure, when 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, as required by 21 CFR 820.75(a).
Specifically, your firm has not validated a repeat (b)(4) cycle or an (b)(4) cycle used to re-sterilize the devices in order to extend thier sterility expiration dates. For Example, Lot (b)(4) were manufactured in (b)(4) and sterilized on (b)(4) with the expiration date of (b)(4) Due to the expiration date, your firm pulled a small number of the devices from these lots to be repackaged and re-sterilized using (b)(4) Upon examination of the twice (b)(4) product, your firm noted a discoloration of the molded plastic components. Because of the discoloration, your firm's contract manufacturer re-sterilized the remaining devices (b)(4) left-hand and (b)(4) right-hand Clearview Systems) using (b)(4) Your firm has not determined the effect of multiple sterilization cycles on the device functionality and material and assured the sterility assurance level.
3. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
Specifically, your firm does not have written procedures for corrective and preventive action.
4. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
Specifically, your firm does not have written procedures for complaint handling.
5. Failure to establish and maintain adequate procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.
Specifically, your firm does not have purchasing control procedures for the Clearview Fixation System to address how your firm will evaluate and document the ability of the contract manufacturers for their ability to meet specified requirements, including quality requirements, and ensure that your contract manufacturers will notify your firm of changes to your devices.
6. Failure to establish and maintain procedures for quality audits and conduct such audits to assure that the quality system is in compliance with established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22.
Specifically, your firm has not established procedures for conducting quality audits.
7. Failure to maintain distribution records to include or refer to the location of required information, as required by 21 CFR 820.160(b).
Specifically, your firm's distribution records do not document lot numbers of the devices distributed.
MEDICAL DEVICE REPORTING
Our inspection also revealed that your firm's Clearview Wrist Fixation Systems™ 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 is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:
Failure to develop, maintain, and implement adequate written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17.
Specifically, your firm does not have any MDR procedures to describe how your firm will receive, identify, document, communicate, and evaluate events that may be subject to the MDR requirements and submit reportable events to FDA within the required timeframes.
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 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 devices have been corrected.
Please notify this office in writing within fifteen 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 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: Mr. Thao Ta, Compliance Officer, Dallas District Office, U.S. Food and Drug Administration, HFR-SW140, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about the contents of this letter, please contact: Mr. Ta at 214-253-5217.
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 lnspectional 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.
Reynaldo R. Rodriguez, Jr.
Dallas District Director