Inspections, Compliance, Enforcement, and Criminal Investigations
Dotolo Research Corporation 05-Apr-05
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Ste. 200
RETURN RECEIPT REQUESTED
April 5, 2005
Mr. Raymond Dotolo
President and CEO
Dotolo Research Corporation
2875 MCI Drive
Pinellas Park, Florida 33782
Dear Mr. Dotolo:
During an inspection of your establishment located at 2875 MCI Drive, Pinellas Park, Florida on January 26-28, 2005, an investigator from the Food and Drug Administration (FDA) determined that your firm manufactures a colonic irrigation system. These products are medical devices as defined under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h).
The investigator documented significant violations of the Quality System (QS) regulations, Title 21, Code of Federal Regulations (CFR), Part 820, and the Medical Device Reporting (MDR) regulations, 21 CFR Part 803. The violations of the QS regulations cause the devices you manufacture to be adulterated within the meaning of Section 501(h) of the Act, 21 U.S.C. 351(h), and the violations of the MDR regulations cause the devices to be misbranded within the meaning of Section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2).
The investigator observed the following violations of the QS regulations:
1. Your firm failed to ensure that an adequate and effective quality control program has been fully implemented and maintained, as required by 21 CFR 820.20. Specifically, employees responsible for quality control stated they do not have the time to obtain necessary training and knowledge of the QS and MDR regulations. Additionally, consultants hired to assist with writing procedures and conducting audits focused on ISO standards rather than FDA regulations. (FDA 483, Item #3).
2. Your firm failed to establish and conduct an internal audit procedure that adequately assures that the quality system is effective and in compliance with the quality system requirements, as required by 21 CFR 820.22. Your internal audit procedure is inadequate because it fails to include and address the QS regulations as criteria for conducting audits. Your internal audit procedure also fails to identify and correct quality problems which were identified in this FDA inspection. (FDA 483, Items #4 & 5).
3. Your firm failed to establish and maintain procedures for implementing and documenting corrective and preventive action, as required by 21 CFR 820 .100(a) and (b). Specifically, FDA observed that: (a) you failed provide users of the carbon filter with a document warning that it can be adversely affected when left unused for long periods of time; (b) your corrective and preventive action (CAPA) procedure does not require that actions be verified/validated for effectiveness prior to implementation and it does not require verification/validation that actions will not be detrimental to the finished device; and (c) your firm failed to adequately document its investigation and corrective actions related to complaints about carbon filters that were failing prematurely and water tubing that was leaking and too thick. (FDA 483, Items #7, 8 & 9).
4. Your firm failed to establish and maintain requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a) . FDA documented the following examples of you firm's noncompliance with this section: (a) your firm fails to verify its claim that the carbon filter included with the Toxygen BSC-UV device removes chlorine and toxins from the water (the filter supplier only claims that the filter is effective in reducing chlorine taste and odor); (b) vendor supplied UV lights are not verified to meet light intensity requirements or the claim that they render 99.99% of microorganisms harmless ; (c) there is no assurance that contract manufacturers have completed process validation used to extrude tubing or to injection mold speculums; (d) there are no records documenting the specifications for 5 micron filters received from vendors; (e) the UV light supplier is not on the approved supplier list; and (f) the Safety Manual included with each Toxygen BSC-UV device states in the equipment section, "FDA Accordance Label for Irrigator, Colonic Indication for Colon Hygiene: Autotoxemia due to poor bowel patterns", is not accurate. (FDA 483, Item #1).
5. Your firm has failed to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 20.70(a). Your firm failed to assure that chlorine residue on the speculum meets acceptable levels after rinsing with chlorine free water and that the bacterial load on hoses and specula leading to the rectum are removed by exposure to UV light. (FDA 483, Item #2).
6. Your firm failed to establish and maintain procedures for the identification,documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). Your firm's design control procedure fails to include any requirement that addresses design changes to labeling or packaging. Also, changes to the labeling in the firm's Owner's Manual, website, etc. within the last 2-4 years did not include design control to verify, validate, or address risk analysis. For example, the firm's website states that Dotolo Research was audited for FDA/ISO/CE Mark licensing in December 2003 and that it passed with high marks . However, prior to January 2005, the most recent FDA inspection of Dotolo Research occurred in 1999 and revealed numerous objectionable conditions . Finally, the design control procedure was not used to verify, validate, or conduct risk analysis of the change to a digital timer to the Toxygen BSC-UV. (FDA 483, Item #6).
7. Your firm failed to maintain complaint files, as required by 21 CFR 820.198(a). There is no documentation of complaints received in 1999, 2000, and 2001 (up to October 31, 2001) and complaints received by the Manufacturing Technician approximately six months prior to this inspection. (FDA 483, Item #10).
Additionally, the FDA investigator observed that your firm has violated the MDR regulations. Your firm failed to develop, maintain, and implement an adequate written MDR procedure that includes an internal system for a standardized review process/procedure for determining when an event meets the criteria for submission, as required by 21 CFR 803.17(a)(2). Specifically, the MDR procedure lacks a full definition of an MDR event, including a definition for a serious injury requiring medical attention and for malfunction. Furthermore, the firm's employees do not understand the definition of an MDR, and the procedure lacks a requirement for a baseline form. (FDA 483, Item #11).
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and FDA regulations. 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,
You should take prompt action to correct these deviations. Failure to promptly correct these deviations 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 penalties. Additionally, no premarket submissions for Class III devices to which QS regulation deficiencies are reasonably related will be cleared until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days of receipt of this letter of any steps that you are still in the process of taking to correct the noted violations, including (1) the time frames within which the corrections will be completed, (2) any documentation indicating the corrections have been achieved, and (3) an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur. Your response should be sent to Timothy J. Couzins, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751, (407) 475-4728.
Director, Florida District