|Company:||D.B.I. America Corp|
|Issuer:||Florida District Office|
|Issued:||March 29, 2007||Closed:||
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Food and Drug Administration
RETURN RECEIPT REQUESTED
March 29, 2007
Mr. Ubiraci R. Fernandes
D.B.I. America Corp.
254 Crystal Grove Blvd.
Lutz, Florida 33548
Dear Mr. Fernandes:
During an inspection of your firm located in Lutz, Florida on January 25, 2007 through January 26, 2007, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures ultrasonic scaler devices, including Swift, Swift Portable, Maxisonic Jet II, Maxisonic II and III, and Biojato. 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 section501(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. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures to adequately control environmental conditions in accordance with 21 CFR 820.70 (c), FDA-483 Observation # 1:
a. Your firm receives p.c. boards wrapped in antistatic bubble wrap for Swift Portable and Maxisonic Jet II devices. These p.c. boards are supposed to be stored inappropriate environmental conditions to protect the p.c. boards from electrostatic discharge (E.S.D). However, multiple p.c. boards were observed touching each other and not being protected from E.S.D in your firm's storage area.
b. Your firm has a wrist strap used to reduce E.S.D but does not periodically test it toverify that it is functioning appropriately.
c. Your firm does not document training of personnel in E.S.D. reduction procedures.
d. Your firm lacks written E.S.D. reduction procedures.
2. Failure to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants in accordance with 21 CFR820.50(a), FDA-483 Observation #2:
a. Your firm does not inspect and document that incoming p.c. boards are adequate for correct placement of components and for quality.
b. Your firm failed to document dates that supplier audits were conducted. In addition, no documentation criteria is covered during supplier audits, such as Electrostatic Discharge reduction procedures and other appropriate sections of the Quality System regulation.
3. Failure to establish and maintain acceptance records which demonstrate that the device is manufactured in accordance with the Device Master Record (DMR), as required by21 CFR 820.184(d). Your firm lacks documentation of testing by employees and testing of finished devices in packaging area, FDA-483 Observation #3.
4. Failure to establish procedures to identify training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. During the inspection your firm could not document that employees can complete soldering procedures per specifications consistently in accordance with 21 CFR 820.25(b). Nor does your firm document a minimum number of successful procedures which employees are required to demonstrate before they are considered qualified for the soldering procedure, FDA-483 Observation #4.
5. Failure to establish and maintain a Design History File (DHF) for each type of device. The investigator requested examples of design verification, design validation and risk analysis and did not receive any documentation, as required by 21 CFR 820.30(j), FDA-483 Observation #5.
6. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met. Your firm lacks written Design Control Procedures including design input, design review, design verification, design validation, and risk analysis. (21 CFR 820.30(a)), FDA-483 Observation #6.
7. Failure to establish and maintain procedures for implementing corrective and preventive actions. During the inspection, the investigator requested examples of written Corrective and Preventive Action (CAPA) procedures, in accordance with 21 CFR 820.100(a), however, no documentation was provided by your firm. It is also required under 21 CFR 820.100 (b) that all activities required under this section, and their results, be documented, FDA-483 Observation# 7.
8. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with quality system regulation. (21 CFR 820.22), FDA-483 Observation #8.
9. Failure to establish quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment in accordance with 21 CFR 820.181 (c). Specifically, the investigator requested, but was not provided with a written procedure covering testing by technicians for Maxisonic devices and covering testing on finished devices in the packaging area, FDA-483 Observation #10.
Our inspection also revealed that your ultrasonic scaler devices noted above are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed to furnish material or information respecting your devices that are required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 C.F.R Part 803 - Medical Device Reporting (MDR) regulation. Significant deviation included:
Failure to develop and maintain written MDR procedures for your ultrasonic scaler, class II devices. During the inspection, the investigator requested MDR procedures, in accordance with 21 CFR 803.17, however, no documentation was provided by your firm, FDA-483 Observation #9.
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. Your response should include documentation of the corrective actions you have taken to assist us in our review. 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: Shari H. Shambaugh, 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 Ms. Shambaugh at (407)475-4730 or FAX: (407)475-4769.
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 andin 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 andquality 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