- Auric Enterprises, Inc. D.B.A. Diack
- Issuing Office:
- Detroit District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Detroit District|
300 River Place
Detroit, Ml 48207
September 3, 2015
Mr. Robert M. Brown
Auric Enterprises, Inc., (d.b.a.) Diack
7755 Narrow Gauge Road
Beulah, MI 49617-9792
Dear Mr. Brown:
During an inspection of your firm located in Beulah, MI, on June 15, 2015 through June 17, 2015 and July 30, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Diack sterilization monitors and VAC sterilization monitors. 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 to affect the structure or any 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from you dated June 26, 2015, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address your response, following the noted violations. These violations include, but are not limited to, the following:
Quality System Regulation
1. Failure to establish and maintain procedures for implementing corrective and preventative action, as required by 21 CFR 820.100(a). For example, no corrective and preventative action procedures were available for review upon request by the investigator. Additionally, during pre-production testing for lot (b)(4) of Diack powder, your firm discovered quality issues with the sulfur you received from your supplier. However, you failed to document the steps taken to investigate, determine a root cause, and to initiate corrective and preventative actions.
2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198. For example, procedures to evaluate complaints and device malfunctions to determine if submission to FDA is required were not available for review upon request by the investigator.
3. Failure to develop, monitor, and control production processes to ensure that your device conforms to specifications, as required by 21 CFR 820.70(a). For example, your firm used expired Zinc Stearate and Methyl Red to produce a batch of Diack powder on October 24, 2014.
4. Failure to establish and maintain procedures to control the design of the device to ensure that design specifications are met, as required by 21 CFR 820.30. For example, no design control procedures were available for review upon request by the investigator.
5. Failure to establish procedures for management review as required by 21 CFR 820.20(c). Specifically, there is no procedure established for conducting management reviews. In addition, no formal management reviews have been documented.
We reviewed your firm’s response for each of the noted violations and conclude it is not adequate. Your firm’s response did not include documentation or evidence of the corrective actions.
Your firm 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of 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 violations 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 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systematic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
We request that you submit your plan for corrective actions based on this correspondence in writing, to the following address:
Food and Drug Administration
Detroit District Office
300 River Place, Suite 5900
Detroit, Michigan 48207
If you have any questions about the content of this letter, please contact Cicely Vaughn at (313) 393-8297.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the FDA 483 issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Art O. Czabaniuk
Acting District Director
Detroit District Office