Inspections, Compliance, Enforcement, and Criminal Investigations
Dupaco, Inc. 21-Nov-06
Department of Health and Human Services
Public Health Service
Los Angeles District
RETURN RECEIPT REQUESTED
November 21, 2006
Gregory P. Jordan
President and CEO
4144 Avenida de la Plata
Oceanside, CA 92056
Dear Mr. Jordan:
During an inspection of your establishment located in Oceanside, California, on September 20 through September, 2006, our investigator determined that your firm manufactures blood/fluid warming sets and other general hospital use products. These products are devices as defined by section 201(h) of the Federal Food, Drug; and Cosmetic Act (the Act), 21 U.S.C. 321(h), because they are intended for use in the cure, treatment, prevention, or diagnosis of a disease or medical condition, or affect the structure or any function of the body.
The above-stated inspection revealed that these devices are adulterated under 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 conformance with the Current Good Manufacturing Practice (CGMP) requirements for medical devices which are set forth in the Quality System regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Significant deviations include, but are not limited to, the following:
1 Failure to review, evaluate, and investigate, any complaint involving the possible failure of a device, labeling, or packaging, to meet any of its specifications, as required by 21 CFR 820.198(c). Specifically, our investigation disclosed that actual complaint samples were not tested and proper tests were not performed. (FDA 483 Observation #2).
2. Corrective and preventive actions have not been verified or validated to ensure that the action is effective and does not adversely affect the finished device as required by 21 CFR 820.100(a)(4). Specifically, the corrective action of scrapping all older sub-assemblies units that produced in 2001 would eliminate or prevent the recurrence of the problem of degradation of materials and bonding of the new sub-assemblies because no verification or validation activities were conducted to ensure that this action would prevent further complaints of degradation and bonding of materials. (FDA-483 Observation # 3).
3. Process control procedures that describe any process controls necessary to ensure conformance to specifications were not defined and implemented as required 21 CFR 820.70(a). Specifically, our investigation determined that your firm continues not to conduct annual burst, creep, and sterility testing to verify the package integrity of the blood/fluid warming sets as required by your written procedures. Additionally, no documentation could be provided describing the pre-determined cycle time established for the heat sealing process of the blood/fluid warming bag sub-assembly. (FDA-483 Observation #4).
4. Sampling plans are not based on valid statistical rationale as required by 21 CFR 820 .250(b). Specifically, no statistical rational could be provided to justify the sampling method for functional testing required for the finished goods inspection for the blood/fluid warming sets. (FDA-483 Observation #5).
5. Failure to evaluate complaints to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR Part 803, as required by 21 CFR 820.198(a)(3). Your firm failed to submit the necessary required information to FDA after becoming aware of device malfunctions pertaining to leakage problems discovered with two lots of blood/fluid warming sets which could pose an unreasonable risk of substantial harm to the public. Specifically, your firm failed to submit a 5-day report to FDA on Form 3500A within 5 workdays of becoming aware that a reportable event necessitated remedial action to prevent an unreasonable risk of substantial harm to the public health. (FDA-483 Observation #1).
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the FDA 483 issued at the close of the inspection may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by the FDA. You also must promptly initiate permanent corrective and preventive action on your quality system.
We acknowledge receipt of your letter dated October 27, 2006, which was prepared in response to our form FDA-483 that was issued to your firm at the conclusion of our inspection on September 27, 2006. Our review has determined that your response does not sufficiently address your understanding deficiencies. For example, your response does not provide complete auditing documentation or the complete results of remedial actions to prevent recurrence of the deficiencies. Your response also does not contain any documentation relating to the cycle times used in your heat sealing processes to ensure conformance to your defined specifications. Please provide the necessary documentation to support the adequacy of these matters so that our office can make the necessary arrangements to verify the corrections. The verification of these corrections will be in the form of a reinspection by our office.
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, no premarket approval applications for Class III devices to which the Quality System regulation deficiencies are reasonably related will be approved until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations 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.
Please notify this office in writing within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. 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.
If you have any questions relating to this letter please contact Senior Compliance Officer, Dannie E. Rowland at 949-608-4448. You may obtain general information about all of FDA's requirements for manufacturers of medical devices through the Internet at http://www.fda.gov.
Please submit your response to:
Pamela B. Schweikert
Director, Compliance Branch
Food and Drug Administration
Irvine, CA 92612-2445
Alonza E. Cruse
Los Angeles District Office