Inspections, Compliance, Enforcement, and Criminal Investigations
Innovatech Medical Resources L.P. d/b/a Medical Services International (MSI) 2/23/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
February 23, 2012
UPS OVERNIGHT MAIL
RETURNED RECEIPT REQUESTED
James L. Fuller, Co-President
Kelly Dean Sanders, Co-President
lnnovatech Medical Resources, L. P.
d/b/a Medical Services International (MSI)
5455 Honeysuckle Road
Midlothian, Texas 76065
Dear Messrs. Fuller and Sanders:
During an inspection of your firm located in Midlothian, Texas, on September 15, 2011, through October 7, 2011, investigators from the United States Food and Drug Administration (FDA) determined that your firm distributes OPUS Magnum 2 Knotless Fixation devices, OPUS SpeedScrew Knotless Fixation devices, OPUS SmartStitch Perfectpasser Suture Cartridges, as well as other devices. 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 they are intended to affect the structure or any function of the body.
As discussed in detail below, MSI re-sterilized these devices and subsequently over-labeled them with extended expiration dates. The act of re-sterilization and over-labeling is considered manufacturing, causing your firm to meet the definition of a manufacturer within the meaning of 21 CFR 803.3.
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:
1. 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).
Your firm failed to validate the (b)(4) sterilization cycle used to re-sterilize implantable and non-implantable devices in order to extend their sterility expiration dates. For example, MSI ordered the re-sterilization of the OPUS Magnum 2 Knotless Fixation, OPUS SpeedScrew Knotless Fixation, OPUS Smartstitch Perfect Passer Suture Cartridge, and various Arthrowands devices without a validated cycle. Additionally, no biological indicators were used to verify lethality of the un-validated process. Your firm's CFO, Mr. Sanders, indicated that he was not aware of the validation process.
2. Failure to establish and maintain procedures for validating the device design to ensure that devices conform to defined user needs and intended use, to include software validation and risk analysis, as required by 21 CFR 820.30(g).
Your firm failed to perform design validation to ensure that re-sterilization of bone fixation devices and their accessories conform to user needs and intended use. Additionally, your firm relabeled these devices with extended expiration dates for up to (b)(4) years without conducting or documenting risk analysis to determine the risks to the device materials or package integrity. Your firm's Co-President, Mr. Fuller, stated that prior to re-sterilization, no risk analysis or product testing was done to determine effect on product, packaging, or sterility.
3. Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d).
For example, between August 31, 2010, and June 3, 2011, your firm sent (b)(4) lots of product to (b)(4) your contract sterilizer, for re-sterilization; however, there was no documentation to show that finished devices continued to meet original specifications, as defined by the original manufacturer.
4. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.
For example, since August 31, 2010, your firm has not evaluated (b)(4) for its ability to meet specified requirements, including quality requirements. Additionally, there was no documentation to define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results. Upon request by the investigator, your firm's Co-President, Mr. Fuller, indicated that your firm did not have a purchasing control procedure.
5. Failure to establish and maintain procedures to ensure that mixups, damage, deterioration, contamination, or other adverse effects to product do not occur during handling, as required by 21 CFR 820.140.
For example, on September 21, 2011, the inside of the MSI delivery van was found to contain an ambient temperature reading of 106° - 107° F. However, (b)(4) OPUS Speed Stitch needles, OM-8850 (lot #1002966), (b)(4) OPUS Magnum Implant Knotless Fixation devices, OM-9026 (lot #1001776), and (b)(4) OPUS SmartStitch Suture Cartridges w/OPUS Magnum Wire, OM-878 (lot #s 02A0802536, 02A0803478, 138313, and 02F0800031), were found inside the van. Their product labeling lists a maximum storage temperature of 77°F.
6. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100.
Your firm's Co-President, Mr. Fuller, confirmed to the FDA investigator, that your firm does not have written procedures for corrective and preventive action.
7. 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).
Your firm's Co-President, Mr. Fuller, confirmed to the FDA investigator that your firm does not have written procedures for complaint handling.
8. Failure to establish and maintain quality system procedures and instructions, as required by 21 CFR 820.20(e).
Your firm does not have any written quality system procedures to outline the structure of documentation used for its quality system. Your firm's Co-President, Mr. Fuller, confirmed to the FDA investigator that your firm does not have any written procedures for quality system.
9. Failure to establish and maintain procedures for quality audits, as required by 21 CFR 820.22.
Both of your firm's Co-Presidents, Mr. Fuller and Mr. Sanders, confirmed to the FDA investigator that your firm never intended to be a manufacturer and that it does not have any quality audit procedures as required by the regulation for a medical device manufacturer.
Our inspection also revealed that your firm's 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 is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 - Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:
Your firm failed to submit a written report to FDA within 10 working days of any correction or removal of a device initiated by the manufacturer to reduce a risk to health posed by the device, as required by 21 CFR 806.10(b).
Between August 8, 2011 and August 12, 2011, your firm initiated a recall of several lots of the following devices: OPUS Autocuff System, OPUS SpeedStitch, OPUS Labrafix System, and Arthrowand devices. The Dallas District Office was not notified in writing of these product removals until your firm submitted a recall notification on September 30, 2011, more than one month after the products were recalled.
Our inspection further revealed that your firm's 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 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:
Your firm failed to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. The inspection confirmed that your firm does not have any procedures for Medical Device Reporting. Upon request by the investigator, your firm's representatives indicated that they were not familiar with any MDR regulations.
Under Section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, Section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [Section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2012.
Therefore, all of your firm's devices are misbranded within the meaning of Section 502(o) of the Act (21 U.S.C. § 352(o)), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under Section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by Section 510(j) of the Act (21 U.S.C. § 360(j)).
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 Ill 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 X. 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 content 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 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.
Reynaldo R. Rodriguez, Jr.
Dallas District Director