| Public Health Service Food and Drug Administration |
Los Angeles District Telephone: 949-608-2900 |
Department of Health and Human Services
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
September 1, 2010 W/L 42-10
Mr. Michael E. Smith, President
Cortechs Labs Inc.
1020 Prospect St., Ste. 450
La Jolla, CA 92037
Dear Mr. Smith:
During an inspection of your firm located at the above-referenced address on July 30 to August 05, 2010, investigators from the United States Food and Drug Administration (FDA or Agency) determined that your firm manufactures and distributes picture archiving communications systems (PACS) over an external server. Under Section 201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are medical 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 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations) (CFR), Part 820.
At the conclusion of the Inspection, the investigator issued to you the Form FDA-483 (List of Inspectional Observations) which identifies a number of significant violations including, but not limited to, the following:
Quality System Violations
1. Procedures for corrective and preventive action have not been adequately established as required by 21 CFR 820.100(a). FDA-483 Item 1.
Specifically,
Your procedure for corrective and preventive action does not include requirements for (1) analysis of non-software related quality data sources; (2) investigating the cause of the nonconformities; (3) identifying actions needed to correct and prevent recurrence; (4) verifying and validating corrective and preventive actions; (5) implementing and recording changes necessary to correct and prevent problems; (6) disseminating information related to quality problems and nonconformances; and (7) submitting information for management review.
2. Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established as required by 21 CFR 820.198(a). FDA-483 Item 2.
Specifically,
Your firm’s complaint handling procedure has requirements for quarterly reporting and trend analysis. There is no evidence of trending. Your firm’s unapproved complaint handling procedure has no requirement for evaluating Medical Device Reporting.
3. Document control procedures have not been adequately established as required by 21 CFR 820.40. FDA-483 Item 3.
Specifically,
Your firm is utilizing a procedure for complaint handling that was not reviewed for adequacy and there is not final approval record by an approval authority. The approved version is considered outdated but has not been obsoleted.
4. Quality audits have not been performed as required by 21 CFR 820.22. FDA-483 Item 4.
Specifically,
Your firm’s internal audit procedure requires an audit at least annually.
5. The results and/or dates of management reviews are not documented as required by 21 CFR 820.20(c). FDA-483 Item 5.
Specifically,
Your firm does not maintain records of periodic reviews as required by the management review procedure.
6. Risk analysis is incomplete as required by 21 CFR 820.30(g). FDA-483 Item 6.
Specifically,
Your design history file for the NeuroQuant software lacks a Hazard Analysis Document (HAD) which is required by your Design Control Methodology procedure.
7. Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been established as required by 21 CFR 820.50. FDA-483 Item 7.
Specifically,
Your firm lacks procedures which identify: (1) how supplier, contractor, and consultant requirements must be met; (2) how suppliers, contractors, and consultants are evaluated and selected; (3) how the evaluation is documented; (4) the type and extent of control over product, services, suppliers, contractors, and consultants; (5) how records are established and maintained; (6) how purchasing data is established, maintained, and approved.
Responding to This Warning Letter
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in enforcement action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.
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, pre-market approval applications for Class III devices to which the Quality System regulation (21 CFR Part 820) deviations are reasonably related will not be approved until the violations related to the subject devices have been corrected.
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 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.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations. You should include in your response documentation, complete verification records or other useful information that would assist us in evaluating your ongoing corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Your written reply should be addressed to:
Blake Bevill, Director Compliance Branch
U.S. Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2445
If you have questions regarding any issue in this letter, please contact Dr. Raymond W. Brullo, Compliance Officer at (949) 608-2918.
Sincerely,
/S/
Alonza E. Cruse
District Director
cc:
Branch Chief
Food and Drug Branch
California Department of Public Health
1500 Capitol Ave. – MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413
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