Steri-Oss Inc. Warning Letter - Dental Regulatory Violations

May 2, 1997
19900 MacArthur Blvd., Ste 300
Irvine, California 92715-2445
Telephone (71 4) 798-7600
WL-22-7
Kenneth A. Darienzo
Chief Executive Officer
Steri-Oss Inc.
22895 Eastpark Drive
Yorba Linda, CA 92887
Dear Mr. Darienzo:
During an inspection of your manufacturing facility conducted between April 7, and April 18, 1997, our investigator determined that your firm manufactures dental implant abutments and dental instruments. These products are devices as defined by Section 201(h) of the Federal Food, Drug and Cosmetic Act (Act).
Our investigation revealed 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, or storage are not in conformance with the Good Manufacturing Practice (GMP) for Medical Device Regulation, as specified in Title 21, Code of FeWal Re~tioM (CFR), Part 820, as follows:
1. Failure to control written procedures for finished device inspection to assure that device specifications are
met [21 CFR 820.160]. For example, our investigation determined that your firm does not document any finished device testing conducted on the dental implants to assure that device specifications are met prior to release to distribution.
2. Failure to maintain labeling integrity and prevent labeling mix-up [21 CFR 820.120 (a)]. For example, our
investigation determined five labeling mix-ups where vour firm conducted no failure investigations or
Inadequate failure investigations, and-conclusions.
3. Failure to ensure that device packaging and any device shipping containers are designed and constructed to protect your dental products from alteration or damage during customary conditions of processing, storage, handling and distribution [21 CFR 820.130].
For example, our investigation disclosed that your firm has had devices returned damage during shipping.
investigation determined to your facility because of Additionally, our that your f& has conducted
studies-of your device packaging and shipping containers which have determined that damage could
result to your devices during customary shipping conditions.
4. Failure to conduct investigations, including conclusions and follow-up measures of devices which
failed to meet their performance specifications [21 CFR 820.162]. For example, our investigation determined at least five situations where your firm conducted no failure investigations of incidents involving devices
which failed to meet their performance specifications.
5. Failure to ensure that device history records for your dental devices demonstrate that these products are
manufactured in accordance with their device master record(s), [21 CFR 820,184]. For example, our investigation disclosed that your firm does not document any dimensional measurements as specified in your written procedures.
This letter is not intended to be an all-inclusive list of deficiencies at your facility and/or with your devices. It iS your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted ir, this letter and in the form FDA 483 issued at the conclusion of the inspection may be symptomatic of serious underlying problems in your firmÇƒÙs manufacturing and quality assurance systems. You are responsible for investigating and determining the ca~lses of the violations identified by the FDA. If the causes are dÇƒ?terxnined to be systems problems, you must promptly initiate pernartent corrective actions.
We acknowledge that you have submitted to this office a response concerning our investigatorÇƒÙ s observations noted on the form FDA 483. It appears that the response is adequate, therefore no submissions for premarket clearance will be withheld for GMP reasons.
You should take prompt action to correct any manufacturing or quality systems deviations identified by your internal audits.
Failure to promptly correct these deviations may be identified in a later comprehensive inspection follow-up inspection, and 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 the letter, of the anticipated date that your facility will be ready for reinspection.
Your reply should be addressed to:
Dannie E. Rowland
Compliance Officer
U.S. Food and Drug Administration
19900 MacArthur Boulevard, Suite 300
Irvine, California 92715-2445
District Di#ector
cc : State Department of Public Health
Environmental Health Services
Att: Chief Food and Drug Branch
601 North 7th Street, MS-357
P.O. BOX 942732
Sacramento, CA 94234-7320