Inspections, Compliance, Enforcement, and Criminal Investigations
BioScience Technologies, Inc. 05-Dec-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
19900 MacArthur Blvd., Ste 300
Irvine, California 92612-2445
Telephone (714) 798-7600
December 5, 2001
Sergio F. Cifurentes
13io Science Technologies, Inc.
3400 Loma Vista Rd., Ste 14
Ventura, CA 93003
Dear Mr. Cifurentes:
During an inspection of your firm located in Ventura, California, from October 25 to 29,
2001, our investigator determined that your firm manufactures dental endosseous
implants, abutments and. accessories. These dental products are devices as defined by
Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).
Our inspection disclosed that these devices are adulterated within the meaning of Section
501 (h) of the Act, in that the methods used in, or the facilities or controls used for
manufacturing, packing, and storage are not in conformance with the Good
Manufacturing Practice (GMP) requirements for the Quality System Regulation, as
specified in Title21, Code of Federal Regulations (CFR), Part 820, as follows:
- No quality audits were conducted during 2000 or 2001 to verify that the quality system is effective in fulfilling your firm?s quality system objectives [21 CFR 820.22].
2. The Device History Record(s) do not include or refer to the location of the
primary identification labeling for each device, any device identification(s) and control
numbers used, or complete acceptance records including the date or signature of the
employees performing the various specified quality assurance activities. Additionally, our
investigation disclosed that there were no history records for-lots of endosseous
implants manufactured in 2001 [21 CFR 820.184].
- The documentation of approval of documents does not include document approval dates or the signature(s) of the approving official. [21 CFR 820.40(a)].
Although, you indicated to our investigator that your firm only exports your devices to
consignees outside of the United States, our investigation determined that your firm does
not comply with the provisions of Section 801(e) of the Federal Food, Drug, and
Cosmetic Act. Specifically, your firm does not have documentation which demonstrates
that the devices accord to the specifications of the foreign purchaser, are not in conflict
with the laws of the country to which they are intended for export, are labeled on the
outside of the shipping package that they are intended for export, and are not sold or
offered for sale in domestic commerce. Therefore your devices are considered to be
adulterated under the Act.
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 Form FDA 483 issued at the
conclusion of the inspection may be symptomatic of serious underlying problems in your
firm?s manufacturing and quality assurance system. You are responsible for investigating
and determining the causes of the violations identified by the FDA. If the causes are
determined to be systems problems, you must promptly initiate permanent corrective
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 pre-market submissions for devices to which the GNP deficiencies are
reasonably related will be cleared until the violations have been corrected. Also, no
requests for Certificates For Exportability will be approved 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 penalties.
Please notify this office in writing within 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 identify and make corrections to any underlying systems
problems necessary to assure that similar violations will not recur. 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) 798-7649.
Please submit your response to:
Thomas L. Sawyer
Director, Compliance Branch
Food and Drug Administration
19900 MacArthur Boulevard, Suite 300
Irvine, CA 92612-2445
Alonza E. Cruse
Los Angeles District Office