Inspections, Compliance, Enforcement, and Criminal Investigations
DP Manufacture Corporation 09-Jan-07
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Ste. 200
RETURN RECEIPT REQUESTED
January 9, 2007
George Echeverri, Vice-President
DP Manufacture Corporation
1460 N.W. 107th Avenue
Miami, Florida 33172-2733
Dear Mr. Echeverri:
During an inspection of your firm located at the above address on September 27, 2006 through October 5, 2006, an investigator from the United States Food and Drug, Administration (FDA) determined that your firm manufactures various models of Power LED dental curing lights. 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.
These violations include, but are not limited to, the following:
1. Your firm failed to ensure that an adequate and effective quality system with oversight by management with executive responsibility has been fully implemented and maintained at all levels of your organization as required by 21 CFR 820.20. The following key components of the Quality System Requirements have not been established:
a. Management having executive responsibility has failed to appoint, and document such appointment, a member of management who is responsible for ensuring that the quality system requirements are effectively established and maintained, as required by 21 CFR 820.20(b)(3).
b. Your firm has not established written procedures for management review at appropriate intervals to ensure that the quality system satisfies the requirements of the QSR and the established quality- policy and objectives of your firm, as required by 21 CFR 820.20(c).
c. A written quality plan that defines the quality practices, resources, and activities relevant to the referenced device has not been established as required by 21 CFR 820.20(d).
2. Your firm has not established and implemented written procedures for the following:
a. Your firm has not established written procedures for conducting internal quality audits and has failed to conduct such audits, as required by 21 CFR 820.22.
b. Your firm has not established written procedures for the identification, documentation, validation or verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i).
c. Your firm has not established and does not maintain written procedures to ensure that all purchased product and services conform to specified requirements, as required by 21 CFR 820.50. Specifically, there are no purchasing control procedures and no control activities have been completed or documented for the supplier of all components used to manufacture the Power LED Curing Light which are received from [redacted]
d. Your firm has not established and has not maintained written procedures to adequately control environmental conditions that could reasonably be expected to have an adverse effect on product quality, as required by 21CFR 820.70(c). There was no electro-static discharge (ESD) procedures or other precautions in effect when electronic circuit boards were being assembled.
e. Your firm failed to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 100.
f. A device master record has not been developed and maintained, as required by 21 CFR 820.181 (c), has for the Power LED Light Curing Device.
g. Device history records are not maintained and written procedures have not been developed that ensure that device history records (DHRs) for each batch, lot or unit are maintained to demonstrate that the device was manufactured in accordance with the device master record (DMR) and the Quality System regulations, as required by 21 CFR 820.184.
h. Your firm failed to establish and maintain written procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR 820.198(a), and no written Medical Device Report (MDR) procedures have been established and maintained, as required by 21 CFR 803.17.
3. Your firm failed to review and evaluate all complaints to determine whether an investigation is necessary; and when no investigation is made, maintain a record that includes the reason and name of the individual responsible for the decision not to investigate, as required by 21 CFR 820.198(b).
4. Your firm failed to document the calibration of equipment as required by 21 CFR 820.72(b)(2). For example, the [redacted] used to conduct final acceptance testing for the Power LED Curing Light has not been documented as having been calibrated.
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.
Your response should be sent to Brant M. Schroeder, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751, (407) 475-4763.
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 the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Director, Florida District