| Public Health Service Food and Drug Administration |
| Los Angeles District 19701 Fairchild Irvine, California 92612-2506 Telephone (949) 608-2900 Fax (949) 608-4415 |
Department of Health and Human Services
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
W/L 43-10
September 8, 2010
Mr. Mun Chang
President/Owner
CeraSys, Incorporated
6475 Knott Avenue
Buena Park, California 90620
Dear Mr. Chang:
During an inspection of your firm located in Buena Park, California on April 28, 2010 through May 4, 2010 investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures CeraSys ZR zirconia dental blocks. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321 (h), this product is a device because it is 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, the 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 (C.F.R.), Part 820. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a).
For example, your firm has not established design control procedures.
Your response dated June 14, 2010, was received after the 15 day time frame for consideration; therefore it has not been reviewed at this time.
2. Failure to establish and maintain procedures for implementing corrective and preventive action as required by 21 CFR 820.100(a).
For example, your firm's procedures for corrective and preventive action have not been adequately established. Specifically, your firm's (b)(4) titled "Corrective and Preventive Action" does not state how to conduct an investigation and to prevent the problem from reoccurring.
Your response dated June 14, 2010, was received after the 15 day time frame for consideration; therefore it has not been reviewed at this time.
3. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
For example, your firm's (b)(4) does not state how to receive, review, and evaluate complaints in a timely manner.
Your response dated June 14, 2010, was received after the 15 day time frame for consideration; therefore it has not been reviewed at this time.
4. Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a).
For example, your firm's process validation activities and results have not been documented. Specifically, the processes for the manufacturing of the CeraSys-ZR blocks have not been validated, and your firm has not qualified (installation, operation, and performance) the (b)(4) machine and (b)(4) used for manufacturing of the ZR blocks.
Your response dated June 14, 2010, was received after the 15 day time frame for consideration; therefore it has not been reviewed at this time.
5. Failure to ensure that all inspection, measuring and test equipment, including mechanical, automated, or electronic inspection and test equipment is suitable for its intended purposes and is capable of producing valid results, and equipment is routinely calibrated, inspected, checked, and maintained, as required by 21 CFR 820.72(a). For example:
a. Procedures to calibrate the (b)(4) and (b)(4) are not established.
b. Regular maintenance for the (b)(4) has not been performed and documented.
c. (b)(4) DOC (b)(4) indicates that maintenance and inspection of the (b)(4) and (b)(4) and checking the equipment parts is to be performed and maintained on a monthly basis. A review of DOC (b)(4) found only one entry, dated 03/04/10, for the (b)(4) and (b)(4) inspection. No other entries were found.
Your response dated June 14, 2010, was received after the 15 day time frame for consideration; therefore it has not been reviewed at this time.
6. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, and to maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a).
For example your firm does not have procedures in place to evaluate suppliers for raw materials and contractors used to repair equipment.
Your response dated June 14, 2010, was received after the 15 day time frame for consideration; therefore it has not been reviewed at this time.
7. Failure to maintain device master records (DMRs) and ensure that each DMR is prepared and approved in accordance with 21 CFR 820.40, as required by 21 CFR 820.181.
For example, your firm does not have a device master record for the CeraSys-ZR blocks.
Your response dated June 14, 2010, was received after the 15 day time frame for consideration; therefore it has not been reviewed at this time.
8. Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, and failure to document training as required by 21 CFR 820.25(b).
For example, your firm has no written training procedures, and no documentation that training has taken place.
Your response dated June 14, 2010, was received after the 15 day time frame for consideration; therefore it has not been reviewed at this time.
Our inspection also revealed that your device 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 C.F.R. Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
Failure to develop, implement, and maintain written MDR procedures as required by 21 CFR 803.17.
For example, during the inspection you were asked if your film had medical device reporting procedures and you responded that you do not have MDR procedures.
Your response dated June 14, 2010, was received after the 15 day time frame for consideration; therefore it has not been reviewed at this time.
Additionally, your device is misbranded under section 502(o), 21 U.S.C. 352(o), 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); or 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). Although your manufacturing facility is currently registered with the FDA, your device listing is not current. Our records indicate that you do not have a device listing for the porcelain powder you use to manufacture Cerasys dental blocks.
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 violations, or similar violations, 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:
Mr. Blake Bevill, Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612
If you have any questions about the content of this letter, please contact Dr. William Vitale, Compliance Officer, at 949-608-2919.
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.
Sincerely yours,
/S/
Alonza E. Cruse
District Director
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