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

WARNING LETTER

December 5, 2001

WL-12-02

Sergio F. Cifurentes

President

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:

1. 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].

3. 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

actions.

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

Sincerely,

Alonza E. Cruse

District Director

Los Angeles District Office