Inspections, Compliance, Enforcement, and Criminal Investigations
Orthopedic Alliance 2/3/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Los Angeles District|
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
SIGNATURE SERVICE REQUIRED
February 3, 2012
Mr. Roger Williams, President
26157 Jefferson Avenue
Murrieta, California 92562
Dear Mr. Williams:
During an inspection of your firm located in Murrieta, California, on July 20, 2011, through September 23, 2011, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures various orthopedic implant devices, including the SC Total Hip System and the SC Ceramic Ball Heads. 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 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. We received a response from Mr. Arnold Neves, Jr., dated September 30, 2011, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a).
For example, your firm's General Counsel Representative stated that there was no corrective and preventive action procedure.
We reviewed your firm's response and conclude that it is not adequate. Your firm stated that two of its employees will be attending a CAPA workshop in early October, 2011, and that the CAPA procedure will be implemented in sixty days. However, neither procedures nor additional procedural details have been submitted for our review. In addition, your firm did not provide a rationale for requiring up to sixty days to complete this corrective action.
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, your firm's General Counsel Representative stated that there was no complaint procedure.
We reviewed your firm's response and conclude that it is not adequate. Your firm stated that its complaint handling program is being developed in conjunction with the Medical Device Reporting program and that these programs should be implemented "within the next thirty to sixty days." However, neither procedures nor additional procedural details have been submitted for our review. In addition, your firm did not provide a rationale for requiring the timeframe of up to sixty days to complete this corrective action.
3. Failure to establish and maintain adequate procedures for control and distribution of finished devices to ensure that only those devices approved for release are distributed and that purchase orders are reviewed to ensure that ambiguities and errors are resolved before distribution, as required by 21 CFR 820.160(a).
For example, the distribution records that include or refer to the name and address of the initial consignee, identification and quantity of devices shipped, the date shipped, and control numbers for hip and knee implants shipped from Orthopedic Alliance, LLC, are not always prepared and maintained.
We reviewed your firm's response and conclude that it is not adequate. Your firm stated that it has begun to implement a new tracking procedure which should be completed in the next month, and that it will send copies of process shipping records upon completion for spinal and orthopedic implants to the district office. However, no tracking procedure was provided, nor was there evidence that the new procedure had been implemented.
Our inspection also revealed that your firm's U2 Total Knee System and SC Total Hip System and SC Ceramic Ball Heads 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 a Medical Device Reporting (MDR) procedure, as required by 21 CFR 803.17.
We reviewed your firm's response and conclude that it is not adequate. Your firm stated that its MDR program is being developed in conjunction with the complaint handling program and that the programs should be implemented "within the next thirty to sixty days." However, no additional detailed procedures have been submitted for our review. In addition, your firm did not provide a rationale for requiring the timeframe of up to sixty days to complete this corrective action.
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:
Director, Compliance Branch
U.S. Food & Drug Administration
Irvine, California 92612-2446
Refer to the Unique Identification Number 235834 when replying. If you have any questions about the contents of this letter, please contact: Jessica Mu, Compliance Officer, at 949-608-4477.
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.
Alonza E. Cruse, Director
Los Angeles District
Cc: Ingeborg Small, Branch Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 997413
Sacramento, CA 95899-7413