Inspections, Compliance, Enforcement, and Criminal Investigations
Medical & Clinical Consortium Inc 02/02/2009
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Los Angeles District
Irvine, CA 92612-2506
RETURN RECEIPT REQUESTED
February 2, 2009
Hector R. Rivera, CEO
Medical & Clinical Consortium Inc.
13740 E. Nelson Ave.
City of Industry, CA 91746
Dear Mr. Rivera:
During an inspection of Medical & Clinical Consortium (MCC), located in City of Industry, California, on March 18, 19, 20, 25, and 31, 2008, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures drugs of abuse test kits. 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 Relations (CFR), Part 820. We received a response from you dated November 5, 2008, concerning our investigators' observations noted on the Form FDA 483, List of Inspectional Observations, that was issued to you on March 31, 2008. 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 fully document process validation activities and results, as required by 21 CFR § 820.75(a).
For example, your firm does not document the validation activities of equipment used in the manufacture of the drugs of abuse test kits. We have reviewed your response and concluded that it is inadequate. Although your response provided the standard operating procedures for the validation of the rotary strip cutter, and the working parameters and operating instructions for the ultrasonic plastic welding machine, your response did not provide the required validation results.
2. Failure to establish and maintain procedures to control the design of the device to ensure that specified design requirements are met, as required by 21 CFR § 820.30(a). For example, your firm does not define, document, and implement procedures to control the design process of the device. We have reviewed your response and concluded that it is inadequate, because it failed to address MCC's lack of design control procedures. Instead, your response, purporting to correlate to this violation as it is described in Observation 9 of the Form FDA 483, addresses unrelated violations described in Observations 7 and 8 of the Form FDA 483.
3. Failure to conduct quality 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.
Specifically, your firm did not perform or document internal quality audits. We have reviewed your response and concluded that it is inadequate. Your response only describes audits of vendor companies, and fails to address your failure to conduct and document internal quality audits at MCC.
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 notification applications for Class Ill 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 the specific 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 these 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.
Your response should be sent to:
J. Lawrence Stevens
Acting Director, Compliance Branch
Food and Drug Administration
Irvine, CA 92612-2506
If you have any questions about the content of this letter please contact Dr. Raymond W. Brullo, Compliance Officer, at (949) 608-2918.
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 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.
Alonza E. Cruse
Los Angeles District Office
Cc: Jeff Farrar, DVM, PhD, MPH
Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413