Inspections, Compliance, Enforcement, and Criminal Investigations
CFS Dental, Inc 1/16/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
RETURN RECEIPT REQUESTED
January 16, 2013
Angel L. Fernandez
CFS Dental, Incorporated
7792 W 2nd Court
Hialeah, Florida 33014-4308
Dear Mr. Fernandez:
During an inspection of your firm located in Hialeah, Florida on December 3, 2012, through December 4, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the CFS Flexible Cartridge device. 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 is intended to affect the structure or function of the body.
The current 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, its 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. The violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures to control the design of your CFS Flexible Cartridge device in order to, ensure that specified design requirements are met, as required by 21 CFR 820.30(a). Specifically, you stated your firm has failed to complete the following:
- Verification of the device design that includes confirmation the design output meets the design input requirements. Additionally, you failed to document the results of design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, as required by 21 CFR 820.30(f).
- Validation of the device design, including risk analysis where appropriate; and you failed to maintain results of design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, as required by 21 CFR 820.30(g).
- Design transfer to ensure the device design is correctly translated into production specifications, as required by 21 CFR 820.30(h). As such, your firm has also failed to ensure your CFS Flexible device can be repeatedly and reliably manufactured using the production specifications when transferred to manufacturing.
- Identification, documentation, validation or where appropriate, verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). Changes made to your initial device design, including material specification and device labeling, lacked change notices, change rationale, and evaluation as to whether the changes would affect device function or quality. Technological comparisons within your device clearance describe the use of trace amounts of a red color pigment during the manufacture of your device; however, you stated you are currently using a red and blue color pigment. You also stated your firm changed the labeling of your device in response to a complaint received by one of your customers stating the device would not heat properly and consistency was not correct. The labeling changes include the removal of the warning, “Do not heat above (b)(4)”; a change in the instructions for use, (b)(4) the time to heat prior to injection from (b)(4) to (b)(4) hours; the removal of the lot number; and the removal of the net weight.
2. Failure to validate with a high degree of assurance and approve according to established procedures a process that cannot be fully verified by subsequent inspection and test as required by 21 C.F.R. § 820.75(a). Specifically, your firm has not performed process validation of your vacuum sealer used to seal the final package of your CFS Flexible device and protect the device from reduced functionally due to humidity intrusion. You stated, during the inspection, the functionality of your CFS Flexible device is adversely affected by humidity intrusion. As such, your firm has failed to validate the sealer used to seal the final packaging to ensure the functionality of your device is maintained.
3. Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a) and their results, as required by 21 CFR 820.100(b). Specifically, you stated you do not have written Corrective and Preventive Action (CAPA) procedures and you do not document information related to quality problems or nonconforming product.
4. Failure to establish and maintain adequate procedures to control product which does not conform to specified requirements, as required by 21 CFR 820.90(a). Specifically, you refer to Sec. 820.90 in your “Complaint and Handling” procedure; however, you have not established procedures to control nonconforming product.
5. Failure to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example: You failed to document and timely investigate a complaint involving for your CFS Flexible Cartridge that alleged the product would not heat properly when used as directed by your labeling. During the inspection, you explained to the investigator that approximately 2 years ago a customer returned approximately 200 cartridges of your CFS Flexible device. A subset of the returned product was observed in your facility and per your instruction was awaiting evaluation. You stated the complaint and any activities performed in response to the complaint for the returned CFS Flexible devices were not documented.
6. Failure to establish and maintain procedures to ensure all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example, you stated your firm has not established purchasing control procedures. Additionally, your firm has not performed an evaluation of your suppliers of nylon and colorants used in the manufacture of your CFS Flexible Cartridge device.
7. 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. For example: You stated you do not have quality audit procedures and do not conduct quality audits.
Our inspection also revealed that your medical devices are 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 as required by or under section 519 of the Act (21 U.S.C. § 360i) and 21 CFR Part 803 - Medical Device Reporting (MDR) regulation. Significant violations include but are not limited to, the following:
Failure to develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, you told the investigator, during the inspection, you were not aware of this requirement and your firm does not have MDR procedures.
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 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 device have been corrected.
Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps you have taken to correct the noted violations, as well as an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions you have taken. If your planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of these activities. If corrections and/or corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed. Your response should be comprehensive and address all violations included in this letter.
Your response should be sent to:
Erica M. Katherine, Compliance Officer
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida, 32751
If you have any questions about the content of this letter please contact: Erica M. Katherine at (407) 475-4731.
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 Form FDA 483, Inspectional Observations (FDA 483), issued at the close out of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management 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.
Emma R. Singleton
Director, Florida District