- Issuing Office:
- Los Angeles District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Los Angeles District|
Irvine, CA 92612-2506
UNITED PARCEL SERVICE
January 5, 2016
WL # 16-16
Mr. Kazem Rassoli
1577 N. Harmony Cir
Anaheim, California 92807
Dear Mr. Rassoli:
During an inspection of your firm located in Anaheim, CA on June 17 through June 22, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures class II dental prosthetic permanent and temporary implants and abutments. 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 to affect the structure or any function of the body.
This inspection revealed that these devices are 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
We received your response, dated July 14, 2015, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, as well as your October 1, 2015 update, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to confirm that design output meets design input requirements during design verification, as required by 21 CFR 820.30(f). Specifically, your design history file for “Cement-On Post for 1) (b)(4) 2) (b)(4)” did not contain or reference any design verification activities to ensure that design output met design input requirements. The Cement-on Post (021) document, which references your titanium abutments to be used for cement restoration process, requires you to meet design input specifications and design specifications, which include the devices’ ability to, 1) meet compatibility (b)(4) with various name brand implant systems (i.e., (b)(4)), and 2) meet functional specifications to include withstanding (b)(4) force at (b)(4) torque. However, there is no documentation to demonstrate these verification activities have been performed.
We reviewed your response and conclude that it is not adequate since you did not complete documentation of your corrections. We understand that you are implementing “Design Controls” SOP-15, Rev. B and planned to complete design verification and validation activities by November 5, 2015. In response to this Warning Letter, you should provide us with an update of these activities, including details (e.g. name, size, 510(k) number) of specific devices involved. You should also assess if all devices manufactured and distributed by your firm meet design verification requirements.
2. A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures, as required by 21 CFR 820.75(a). Specifically, you failed to implement your “Process Validation” SOP-25, Rev. A. You installed and operated (b)(4) machines since 2012 to manufacture your devices, but you failed to perform process validation to ensure that (b)(4) machines are qualified and devices manufactured consistently meet all predetermined specifications. Devices manufactured include Cement-On Post HEXED, TiteFit (Part no. 13347), Cement-On Post 4mm COLLAR, 4.5mm PROFILE (Part no. 13040) and Implant Analog Aluminum (Part no. 11013-01).
We reviewed your response and conclude that it is not adequate since you did not provide complete documentation of your corrections. We understand that you are implementing your “Process Validation” SOP-25, Rev. B and planned to complete process validation activities by October 30, 2015. In response to this Warning Letter, you should provide us with an update of these activities, including details (e.g. name, size, 510(k) number) of specific devices involved.
3. Failure to adequately validate software used as part of production and quality systems for its intended use according to an established protocol, as required by 21 CFR 820.70(i). Specifically, you did not validate any software programs of your (b)(4) machines used to manufacture all your devices. Per your employee, there are hundreds of tooling programs to make hundreds of different device parts as specified in your product catalogue. Examples include, but are not limited to, software and tooling programs for the following devices: Cement-On Post HEXED, TiteFit (Part no. 13347), Cement-On Post 4mm COLLAR, 4.5mm PROFILE (Part no. 13040) and Implant Analog Aluminum (Part no. 11013-01).
We reviewed your response and conclude that it is not adequate since you did not provide complete documentation of your corrections and not enough details of your proposed corrections were submitted for our review, such as the scope of the software validation and which devices are covered under the software validation. We understand that you are implementing your “Process Validation” SOP-25, Rev. B and planned to complete software validation by October 30, 2015. In response to this Warning Letter, you should provide us with an update of these activities, including details of specific devices involved.
4. Failure to review, evaluate and investigate, where necessary, complaints involving the possible failure of a device to meet any of its specifications, as required by 21 CFR 820.198(c). Specifically, you failed to investigate the following complaints:
a. Complaint 14-01 (4/22/2014): customer reported that abutment (Part no. AD910, Lot no. 011524) is not compatible with implant system used by the customer. You stated to our investigator your firm often sends abutments to customers based on implant information obtained through phone orders. The complaint filed contained minimal information, and you determined no investigation was necessary without obtaining information on how the wrong abutment was sold and used by the customer and whether further evaluation and corrective action would be warranted.
b. Complaint 14-02 (10/5/2014): customer reported that Cement-On Post titanium (Part no. AA515) has a burr inside the abutment. You determined no investigation was necessary because the customer removed the burr. The complaint file included minimal information and you failed to obtain additional device information to evaluate if the non-conformance is related to your manufacturing and quality control operations, and determine whether investigation into other lots is warranted. Such investigation can help determine if CAPA is needed to prevent recurrence.
c. Complaint 14-03 (10/9/2014): customer reported UCLA plastic abutments being fractured (Model AB200, AA200 and P200, Lot no. 011941, 011869 and 012044). The complaint file included minimal information and did not include information on torque specification, torque applied by the customer, or the total number of devices fractured or fracture frequency. However, you determined no investigation was necessary because “THEY DO CRACK WHEN SOMEONE TIGHTENS TOO MUCH THE SCREW.” You failed to investigate the device malfunction and determine if other lots are affected, and whether further investigation or corrective action would be warranted.
We reviewed your response and conclude that it is not adequate. Your response states your corrective actions include re-training employees on complaint handling and closure of these complaints. However, these complaints were already closed in 2014 and you did not provide additional evidence to show adequate investigations have been performed for these complaints.
5. Failure to establish and maintain procedures for design review as required by 21 CFR 820.30(e). Specifically, your design history file for “Cement-On Post for 1) (b)(4)” did not contain or reference any design review documents.
We reviewed your response and conclude that it is not adequate since you did not complete documentation of your corrections. We understand that you are implementing “Design Review Form” FRM-15-04, Rev. A and corrective action is ongoing. In response to this Warning Letter, you should provide us with an update of these activities, including details (e.g. name, size, 510(k) number) of specific devices involved.
During the inspection it was also revealed that your firm is marketing your devices for use with dental implant systems that are not listed in your cleared indications. Your dental prosthetic abutments and implant 510(k)s have FDA cleared “Indications for Use” which list a limited number of particular manufacturers’ implant systems, with specified sizes, with which your devices are intended to be used. However, your catalogs and website claim “compatibility” and that your devices are “fully compatible” with additional implant systems that are outside the scope of the 510(k)s cleared for your devices. FDA is not aware of any scientific substantiation for these compatibility claims. The inspection revealed no compatibility data, and you have informed us that your firm lacks validation or verification of device compatibility, device specifications, and functional specifications. These claims of compatibility have the potential to mislead.
Compatibility is critical to device safety and effectiveness because the implant abutment interface is critical. If micro motion is encountered, implant failure may occur, requiring removal of the implant body. Accordingly, addition of a “compatible” implant system to your indications for use is a major change in intended use from your original premarket clearance submission, and requires a new 510(k). Therefore, your devices are adulterated within the meaning of section 501(f)(1)(B), 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. § 360(e), or approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). Your devices are also misbranded under section 502(o) of the Act, 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) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)]. The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm.
The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Your firm 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of 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 violations 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 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to: Los Angeles District Office. Refer to the Unique Identification Number (CMS case #474517)when replying. If you have any questions about the contents of this letter, please contact: Jessica Mu, Compliance Officer at 949-608-4477.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
LCDR Steven Porter, Acting Director
Los Angeles District