Inspections, Compliance, Enforcement, and Criminal Investigations
Digicare Biomedical Technology, Inc. 26-Apr-05
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
RETURN RECEIPT REQUESTED
April 26, 2005
Jose Eduardo Miranda, President
Digicare Biomedical Technology, Inc.
107 Commerce Road
Boynton Beach, Florida 33426-9365
Dear Mr. Miranda:
During an inspection of your establishment located in Boynton Beach, Florida on January 25-28, 2005, an investigator from the Food and Drug Administration (FDA) determined that your establishment manufactures pulse oximeters and multiparameter patient monitors. These products are Class II medical devices under sections 201(h) and 513(a)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h) and 360c(a)(1)(B). The investigator documented significant violations from the Quality System (QS) regulation, Title 21, Code of Federal Regulations (CFR), Part 820. These violations cause the devices you manufacture to be adulterated within the
meaning of Section 501(h) of the Act, 21 U.S.C. 351(h).
The investigator noted the following violations of the QS regulation:
1. Management with executive responsibility has failed to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives, as required by 21 C.F.R. 820.20(c). Specifically, your firm has not conducted management reviews since 1998 (FDA 483, Item #7).
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 C.F.R. 820.22. The QS regulation, 21 C.F.R. 820.22, requires that: (a) quality audits be conducted by individuals who do not have direct responsibility for the matters and shall be taken when necessary; (b) a report of the results of each quality audit, and reaudit(s), where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited; and (c) the dates and results of quality audits and reaudits shall be documented.
However, your firm lacked major steps for effective internal audits, including design control, software validation, corrective and preventive action (CAPA), and Electrostatic Discharge (ESD) reduction activities Also, the individual conducting the audits lacks the necessary training and experience to conduct such audits and failed to identify deficient quality matters. Furthermore, audits were conducted by the Quality Assurance Manager, who has direct responsibility over matters being audited. This observation was repeated from the previous inspection and the untitled letter issued in September 2003 (FDA 483, Item #6).
3. Your firm failed to establish and . maintain procedures for implementing and documenting CAPA, as required by 21 C.F.R. 820.100. Your firm did not perform various CAPA activities, including an analysis of sources of quality data, documentation of nonconformities, investigations into the causes of nonconformities, and submission of information on quality problems and CAPA actions for management review (FDA 483, Item #3).
4. Your firm failed to establish and maintain procedures to adequately control environmental conditions, including the verification of the environmental control system, when such conditions could reasonably be expected to effect product quality, as required by 21 C.F.R. 820.70(c). Specifically, your ESD is inadequate because: (a) al! four wrist straps used by device assemblers failed the your firm's established test; (b) wrist straps and mats are not routinely cleaned and are not checked for proper grounding and surface resistivity; (c) daily surface resistivity tests of wrist straps were conducted with meters not designed for this use and-that had expired calibration dates; (d) two of four assemblers failed to perform the wrist strap test according to your firm's ESD written procedures; (e) ESD training is not conducted at designated intervals; (f) out of specification ESD test results were not investigated and corrective actions were not taken prior to production; (g) work benches where pc boards are handled were observed with materials such as paper and Styrofoam cups, which can generate strong electrostatic fields; (h) in-process pc boards were stored on shelves without anti-static bags or other protection against ESD. This observation was repeated from the previous inspection and the untitled letter issued in September 2003 (FDA 483, Item #4).
5. You failed to ensure that all inspection, measuring, and test equipment is suitable for its intended purposes, to maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained, and to take remedial action to reestablish limits when accuracy and precision limits are not met, as required by 21 C.F.R. 820.72 (a) and (b). The following test equipment used for in-process testing were found being used with expired calibration dates: Fluke 87 III True RMs Multimeter SNs: 71820463, Exp. 718/2004 and 66240307, Exp. 9/1712004 (FDA 483, Item #5).
6. You have failed to establish and maintain procedures for validating the device design, as required by 21 C.F.R. 820 .30(g). The Life Window 6000 Multi-Parameter Patient Monitoring System was not validated. This observation was repeated from the previous inspection and the untitled letter issued in September 2003 (FDA 483, Item #1).
7. You have failed to establish and maintain a Device History File (DHF) for each type of device that contains or references the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of the QS regulation, as required by 21 C.F.R. 820.30(j). Your firm did not conduct and document design verification, design validation, design review, or risk analysis in the DHF for the Life Window 6000 Multi-Parameter Patient Monitoring System. This observation was repeated from the previous inspection and the untitled letter issued in September 2003 (FDA 483, item #2).
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