Inspections, Compliance, Enforcement, and Criminal Investigations
Magnificent Medical Equipment, Inc. (dba Tony Riso Company) 04-Sep-08
Department of Health and Human Services
Public Health Service
555 Winderley Place, Ste. 200
Telephone: (407) 475-4700
RETURN RECEIPT REQUESTED
September 4, 2008
Ralph A. Milliken
Magnificent Medical Equipment, Inc.
dba Tony Riso Company
2641 NE 186th Terrace
Miami, Florida 33180-2624
Dear Mr. Milliken:
During an inspection of your firm located in Miami, Florida on April 2, 2008, through April 4, 2008, investigator(s) from the United States Food and Administration (FDA) determined that your firm manufactures the [redacted] 25/30 Ultrasonic Scaler. Under section 201(h) of the Federal Food, Drug, an 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. At the close of the inspection, you were issued a Form FDA-483, List of Inspectional Observations that identified a number of violations, including, but not limited to, the-following:
1. Failure to maintain device history records (DHRs) to demonstrate that your devices are manufactured in accordance with the device master records (DMRs), as required by 21 CFR 820.184(d). Specifically, your firm does not have records to demonstrate that your components and finished devices meet device specifications. Your firm failed to document incoming inspection of bare p.c. boards from the supplier, failed to document inspection of populated p.c. boards, and failed to document final inspection of your medical devices.
2. Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a). For example, your firm failed to do Hipot testing of your medical devices to verify that the electrical insulation is sufficient to protect the operator from electrical shock.
3. Failure to ensure that the DMRs include, or refer to the location of, quality assurance procedures and device specifications, as required by 21 CFR 820.181(a) and (c). For example, your firm's DMRs neither include nor refer to acceptance criteria for incoming components or to specifications for the components and for the finished devices.
4. Failure to establish and maintain procedures to adequately control environmental conditions that could reasonably be expected to have an adverse effect on product quality, as required by 21 CFR 820.70(c). For example, populated p.c. boards were observed stacked on top of each other and not protected form possible electrostatic discharge (ESD) on storage shelf. Also your firm lacks a written ESD reduction procedure.
5. Failure to establish and maintain procedures to ensure that inspection, measuring, and test equipment is routinely calibrated, inspected, checked and maintained, as required by 21 CFR 820.72(a). For example, your firm has not calibrated the equipment (meters, etc.) used in the testing of your medical devices.
6. Failure to validate with a high degree of assurance and approve according to established procedures a process, where the results of that process cannot be fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a). For example, your firm provides a partial recommended sterilization cycle for steam autoclave and chemical vapor methods in its labeling for inserts. Your firm has no sterilization validation of these recommended cycles to demonstrate sterility or to demonstrate that recommended cycles will not adversely affect the materials used in those inserts.
7. Failure to establish and maintain procedures for implementing corrective and preventative action (CAPA), as required by 21 CFR 820.100(a), and failure to document all CAPA activities, as required by 21 CFR 820.100(b). Your firm has not established any CAPA procedures.
8. 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. Your firm has not conducted any internal audits and has no written internal audit procedure.
9. 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). Your firm has not established any procedures for design control.
10. Failure to establish (define, document, and implement) and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Complaints, as defined in 21 CFR 820.3(b), must be evaluated to determine whether they represent events that must be reported to FDA under 21 CFR Part 803-Medical Device Reporting (MDR) regulation and whether an investigation is necessary. 21 CFR 820.198(a)(3), (b), and (c). When an investigation is made, a record of the investigation must be maintained, and must include dates and results of the investigation and any corrective action taken. 21 CFR 820.198(e). Your firm has not established the requisite complaint-handling procedures. For example, your firm did not identify which Service Reports constituted "complaints," as defined 21 CFR 820.3(b), and which of these complaints necessitated investigation under 21 CFR 820.198(b) and (c). Moreover, your firm failed to conduct and document an investigation as required for the following complaints reflected in Service Reports (and identified by Service Report Invoice Numbers), which involved the possible failure of the device, labeling, or packaging to meet its specifications and for which there was no evidence that an investigation had been performed for a similar complaint and that another investigation was unnecessary: Invoice #s 3065, 3187, 3342, 3343, 3721, 3729, 4284, 4307, 4770, 4806.
Our inspection also revealed that your 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 is 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 deviations include, but are not limited to, the following:
Failure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. Your firm has no written 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.
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 violation(s), 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: Winston R. Alejo, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions about the content of this letter please contact: Mr. Alejo 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 Inspectional Observations, Form FDA 483 (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 these violations, and take prompt actions to correct the violations and to bring your products into compliance.
Emma R. Singleton
Director, Florida District