Inspections, Compliance, Enforcement, and Criminal Investigations
BioSafe America Corporation 28-Oct-08
Department of Health and Human Services
Public Health Service
Los Angeles District
RETURN RECEIPT REQUESTED
October 28, 2008
Robert W. Scholler, Chairman of the Board/Owner
Bio-Safe America Corporation
3250 South Susan Street, Suite B
Santa Ana, California 92704
Dear Mr. Scholler:
During an inspection of your firm located in Santa Ana, California on June 2 through June 27, 2008, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures a laminar flow unidirectional clean air system. 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 this device is 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. These violations include, but are not limited to, the following:
1. Failure to establish and maintain a quality system that is appropriate for the specific medical devices designed or manufactured and that meets the requirements of the QS regulation, as required by 21 CFR 820.5. Your firm has no quality system.
2. Failure of management with executive responsibility to establish its policy and objectives for, and commitment to, quality and to ensure that the quality policy is understood, implemented, and maintained at all levels of the organization, as required by 21 CFR 820.20(a). Your firm has no quality policy.
3. Failure to establish quality system procedures and instructions, as required by 21 CFR 820.20(e). For example, your firm has no quality system procedures and instructions for quality audits, document controls, installation, and servicing.
4. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit to ensure that all complaints are processed in a uniform and timely manner, that oral complaints are documented upon receipt, and that complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR 803, Medical Device Reporting, as required by 21 CFR 820.198(a). Your firm has no complaint-handling procedures.
5. Failure to establish and maintain procedures for implementing corrective and preventive actions (CAPA), as required by 21 CFR 820.100(a). Your firm has no CAPA procedures.
6. 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. Your firm has no such purchasing control procedures.
7. Failure to establish and maintain procedures for acceptance activities, including inspections, tests, or other verification activities, as required by 21 CFR 820.80(a). Your firm has no such procedures.
Our inspection also revealed that your laminar flow unidirectional clean air system is 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 (MDR) regulation. Significant deviations include, but are not limited to, the following:
Failure to develop a written MDR procedure, as required by 21 CFR 803.17. Your firm has no written MDR procedure.
Our inspection also revealed that the laminar flow unidirectional clean air system is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to
section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
Our inspection also revealed that the laminar flow unidirectional clean air system is misbranded under section 502(o) of the Act in that the device was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510, 21 U.S.C. 360, was not included in a list required by section 510(j), 21 U.S.C. -360(j), and a notice or other information respecting the device was not provided to the FDA as required by section 510(k), 21 U.S.C. 360(k).
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 approval applications for Class III 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 violation(s), or similar violation(s), 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 those 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 92612-2446
If you have any questions about the content of this letter please contact: MaryLynn Datoc, Compliance Officer, at 949-608-4428 or FAX 949-608-4401.
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 Inspectional Observations, Form FDA 483 (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
Cc: California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413