Inspections, Compliance, Enforcement, and Criminal Investigations
Protech Professional Products, Inc. 7/24/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
July 24, 2014
ProTech Professional Products, Inc.
2900 Commerce Park Drive, Suite 10
Boynton Beach, Florida 33426
Dear Mrs. Bloch:
During an inspection of your firm located in Boynton Beach, Florida on December 11–13, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a specification developer of the ProTech Plus Self Cure Hard Reline and Repair Acrylic Powder and Liquid devices product line. 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.
Our inspection revealed that after the ProTech Plus Hard Reline and Repair Acrylic received 510(k) clearances (K983547 and K925062), the following significant modifications were made to the denture base resins:
- Your firm currently uses a “(b)(4)” process during the manufacturing process. The 510(k) clearance is for a product which utilizes a “(b)(4)” process. The “ (b)(4)” process uses component ingredients that are different from those listed in the 510(k) clearance.
- Your firm currently uses the coloring components Pigment Red 187, Pigment Yellow 180, and Pigment Red 149. The 510(k) clearance lists colorant components as FD&C Red 40.
Our inspection revealed that the ProTech Plus Self Cure Hard Reline and Repair Acrylic are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), in that a notice or other information respecting the aforementioned modifications to the denture base resins were not provided to the FDA as required by section 510(k), 21 U.S.C. 360(k), and 21 CFR 807.81(a)(3)(i). 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.
A follow up inspection may be required to assure that corrections and/or corrective actions are adequate.
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/or 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 awarding of contracts.
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.
In addition, FDA has noted nonconformances with regards to section 501(h) of the Act (21 U.S.C. § 351(h)), which are deficiencies within your firm’s quality system pertaining to current good manufacturing practice requirements specified in the Quality System regulation found at 21 CFR Part 820. These nonconformities 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 the specified design requirements are met, as required by 21 CFR § 820.30(a)(1).
For example, you have no written design control procedures to control the design of the ProTech Plus Self Cure Hard Reline and Repair Acrylic Powder and Liquid devices including not having documentation of requirements for the labeling of the products. You also failed to provide evidence that you have established and maintained Design History Files for your product(s), including but not limited to: ProTech Plus Hard Reline and Repair Acrylic, ProTech Plus Denture Base Acrylic (heat-cure), UBAR Metal Bonding and Repair Acrylic (self-cure), PERMAFIX bonding material (self-cure), Soft Reline Acrylic (heat or self-cure).
We have reviewed your response and have concluded that it is inadequate. Your firm has not adequately addressed the requirements of 21 CFR § 820.30(a)(1) nor have you informed us of any specific plan or provide evidence of immediate corrections and systemic corrective actions.
2. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR § 820.50.
For example, you have no written procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.
Although you provided Purchasing Control Policy, SOP 7.4-1, Rev C, effective January 7, 2014, as part of your written response, it is inadequate. You failed to provide objective evidence that the ProTech denture relining, repairing, and rebasing resin can be consistently fulfilled by your contract manufacturer according to predetermined specifications. Further, your response does not include evidence to demonstrate that you have evaluated the contract manufacturer(s) of the ProTech Plus Hard Reline and Repair Acrylic, ProTech Plus Denture Base Acrylic (heat-cure), UBAR Metal Bonding and Repair Acrylic (self-cure), PERMAFIX bonding material (self-cure), Soft Reline Acrylic (heat or self-cure), in accordance with your revised procedure.
3. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, including procedures for investigating the causes of nonconformities relating to product, processes, and the quality system, and for verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device. [21 CFR § 820.100(a)(2) and 21 CFR § 820.100(a)(4)]
For example, upon further review by Compliance, your Corrective and Preventive Action procedure does not require an investigation to determine the cause of the non-conformance, if possible. Your Corrective and Preventive Actions have not been verified and/or validated to show that the procedure is effective and will not adversely affect the finished device.
We have reviewed your response and have concluded that it is inadequate. Your corrective action involves revising the Corrective and Preventive Action procedure, SOP 8.5, to clarify that all Corrective and Preventive Actions (CAPAs) will be verified and/or validated as effective, and that they will not adversely affect the finished device. However, your revised procedure does not include all applicable provisions for implementing CAPAs.
4. Although not listed on the FDA Form 483, further review by Compliance revealed a failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints, as required by 21 CFR. § 820.198(a).
For example, Complaint Handling Procedure, (SOP 8.5.1, Ver. Original, dated May 7, 2013) does not include provisions for evaluating and processing all complaints in a uniform and timely manner, as required by 21 CFR. § 820.198(a)(1); evaluating all complaints to determine whether an investigation is necessary or, if no investigation was conducted, the requirement that such justification is appropriately documented and approved by management, as required by 21 CFR § 820.198(b); and that any complaint representing an event which must be reported to FDA under 21 CFR 803, be reviewed, evaluated, and investigated, as required by 21 CFR § 820.198(d).
Your firm’s response to this letter should be sent to: Randall L. Morris, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751. Refer to the Unique Identification Number CMS 420411 when replying. If you have any questions about the contents of this letter, please contact: Randall L. Morris at (407) 475-4741.
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.
Elizabeth W. Ormond
Acting Director, Florida District
cc: Adam C. Bloch
ProTech Professional Products, Inc.
2900 Commerce Park Drive, Suite 10
Boynton Beach, Florida 33426