Inspections, Compliance, Enforcement, and Criminal Investigations
Healex Products Inc. 8/19/10
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
FAX: (781) 596-7896
August 19, 2010
VIA FEDERAL EXPRESS
Jacqueline C. Hodosh
Healex Products Inc.
2 Harian Road
Providence, Rhode Island 02906
Dear Mrs. Hodosh:
During an inspection of your firm located in Providence, Rhode Island on June 2, 4, 10 and July 2, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Preserve Plus, Preserve Temp and Desens-Ionomer dental cements and desensitizing agents. 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 are intended to affect the structure or 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. In addition these devices are misbranded within the meaning of section 502(o). We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements, as required by 21 CFR 820.50(b).
For example, you have no written procedures to ensure that all contract manufactured devices, including the dental cements, Preserve Plus, Preserve Temp and Desens-Ionomer, or otherwise received products and services conform to specified requirements
2. 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)(1).
For example, you have no written design control procedures to control the design of the dental cements Preserve Plus, Preserve Temp and Desens-Ionomer. You were unable to provide a design history file for any device or documentation of changes to any device.
3. Failure to establish and maintain procedures for receiving, reviewing and evaluating complaints as required by 21 CFR 820.198(a).
For example you do not have a written complaint procedure for receiving, reviewing and evaluating complaints associated with the medical devices you manufacture including Preserve Plus, Preserve Temp and Desens-Ionomer.
4. Failure to establish QS procedures and instructions as required by 21 CFR 820.20(e).
For example, there are no written quality system procedures and instruction for the manufacture and distribution of your dental cements including Desens-lonomer, Preserve Plus and Preserve Temp. During the inspection you stated to our investigator that you are unfamiliar with the Medical Device Quality System regulations. You were unable to provide any documentation or procedures for control of device design, specifications for contract manufacture or handling of complaints.
Furthermore, our inspection revealed that you have not registered your facility or listed your devices as required by the Act. Failure to register a facility and list devices with FDA constitutes misbranding under Section 502(o) of the Act, 21 U.S.C. § 352(o), in that your devices were manufactured, prepared, propagated, compounded or processed in an establishment not duly registered under section 510, 21 U.S.C. § 360. You can obtain the registration form from our website at http://www.fda.gov.
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.
Refer to Warning Letter NWE-19-10 when replying to this letter. Your response should be sent to: Anthony P. Costello, Compliance Officer, Food and Drug Administration, 1 Montvale Avenue, 4" Floor, Stoneham, MA 02180 If you have any questions about the content of this letter please contact: Mr. Costello at 781-596-7716.
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, 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.
Mutahar S. Shamsi
Acting District Director
New England District