Inspections, Compliance, Enforcement, and Criminal Investigations
Accurate Set Inc. 4/26/10
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054
Telephone (973) 331-4906
April 26, 2010
RETURN RECEIPT REQUESTED
Mr. Cornell Adams
Accurate Set Inc.
1199 Broad Street
Newark, NJ 07114
Dear Mr. Adams:
During an inspection of your firm located in Newark, New Jersey, on October 30, 2009 through November 13, 2009, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer, repacker, and distributor for Setacure (Self curing Polymer), Heat and Self Cure Tooth Shade Acrylic Powders, 20-minute Cure Acrylic (Self Cure), Setatone Extra-Hard Crown and Bridge Monomers, Setatone Crown and Bridge Monomers, and Temporary Acrylic for Crown and Bridge. 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 there 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.
At the close of the inspection, a FDA Investigator discussed with you objectionable conditions observed during the inspection. A Form FDA-483 was issued. We received no written response to Form FDA-483 that was issued to you.
The Act requires manufacturers of medical devices to obtain marketing clearance or approval from FDA before they may offer them up for sale. This requirement protects the public health by helping to ensure that new medical devices are shown to be either both safe and effective or substantially equivalent to other devices already legally marketed in the United States. The FDA inspection revealed that your 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA) as required by 21 CFR § 820.100(a).
Specifically, your firm's Quality System Procedures (8.53 Corrective Action, dated March 16, 2004 & 8.53 Preventive Action, dated March 22, 2004) do not include requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems.
2. Failure to review, evaluate, and investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications, and failure to maintain records of an investigation as required by 21 CFR § 820.198(c), (d), and (e).
Specifically, your complaint record for the Heat Cure Acrylic did not include information to show whether an investigation was conducted, what caused the material to not set properly, and whether any CAPA was implemented as required by your written procedure for handling complaints, dated April 1, 2004.
3. Failure to establish and maintain procedures that address the need to evaluate and document an investigation in order to control product that does not conform to specified requirements as required by 21 CFR § 820.90(a). Specifically, your written procedure for Control of Nonconforming Product (Quality System Procedure 8.3, dated March 22, 2004) does not require an evaluation of the need for a documented investigation for nonconforming products.
4. Failure to maintain device history records (DHR's) as required by 21 CFR § 820.184. Specifically, your firm has failed to implement procedure 7.1-2, Device History Record, dated March 22, 2004, in order to ensure that the device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record and the Quality System regulation. For example, there was a lack of device history records for the one pound 20 minute Cure Acrylic (self cure) powder and two eight-ounce Setacure Monomer, Lot # 4272009, packed on April 27,2009.
5. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system as required by 21 CFR § 820.22. Specifically, quality audits were not conducted at sufficient regular intervals, as prescribed by your Internal Audit Procedure, 8.22, dated March 22, 2004, in order to verify that your quality system is effective in fulfilling your quality system objectives. Your internal audit procedure specifies that internal audits are to be scheduled at least (b)(4) or more frequently if the number of corrective actions warrants additional attention to the quality system. However, your firm has not conducted any internal audits since the previous inspection which was conducted on September 23, 2004.
Our inspection also revealed that your Setacure (Self curing Polymer) and Heat and Self Cure Tooth Shade Acrylic Powder devices are adulterated under section 501(f)(1)(B) of the Act [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. 360e(a)] or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act [21 U.S.C. 360j(g)]. These devices are also misbranded under section 502(o) the Act [21 U.S.C. 352(o)] because you did not notify the agency of your intent to introduce these devices 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) of the Act [21 U.S.C. 360(k)] is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that must be submited in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
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 FDA 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: Robert J. Maffei, Compliance Officer, U.S. Food and Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey, 07054. If you have any questions about the content of this letter, please contact Mr. Maffei at 973-331-4906.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) 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 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.
New Jersey District Office