Inspections, Compliance, Enforcement, and Criminal Investigations
Danmar Product, Inc. 06-Sep-07
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
September 6, 2007
Daniel C. Russo
President and C.O.O
Danmar Products Inc.
221 Jackson Industrial Dr.
Ann Arbor, MI 48103
Dear Mr. Russo:
During an inspection of your establishment located in Ann Arbor, Michigan, on June 1 through 14, 2007, investigators from the Food and Drug Administration (FDA) determined that your firm manufactures the Michigan Cranial Helmet and the Cranial Adjustive Prosthesis. 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.
The above-stated 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 complete design history files to demonstrate that the devices were developed in accordance with an approved design plan and the QS regulation, as required by 21 C.F.R. § 820.30(j). For example, no design plan has been established for the Michigan Cranial Helmet and the Cranial Adjustive Prosthesis per your design control procedures. In addition, not all elements of design controls have been specifically identified, as required by 21 C .F.R. 820.30(a).
2. Failure to establish and maintain procedures for implementing corrective and preventive actions (CAPA), as required by 21 C.F.R. § 820.100(a). For example, there are no CAPA procedures describing the following: analyzing processes, work operations, quality audits, service records, returns, investigating the cause of nonconformities, verifying or validating corrective actions, implementing changes, and ensuring the information related to the non-conformities is disseminated to the correct individuals.
3. Failure to evaluate and review complaints to determine if an investigation is necessary, as required by 21 C.F.R. § 820.198(b). For example, the trending data reviewed for complaints did not address any of the cranial products returned from customers.
4. Failure to establish and maintain a procedure that ensures complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803, as required by 21 C.F.R. § 820.198(a)(3).
5. Failure to establish and maintain procedures for acceptance activities, as required by 21 C.F.R. § 820.80(a). For example, there are no acceptance criteria for receiving in-process and finished device testing for the manufacturing of the cranial devices.
6. Failure to establish complete Device Master Records (DMR) that include or refer to the location of device specifications and quality assurance procedures, as required by 21 C.F.R. § 820.181(a) and (c).
7. Failure to use purchasing documents that include, where possible, an agreement from the supplier to notify you of any changes in the product or service, as required by 21 C.F.R. § 820.50(b).
8. Failure to establish procedures for quality audits and conduct such audits to ensure 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 C.F.R. § 820.22.
9. Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 C.F.R. § 820.25(b).
10. Failure to establish and maintain procedures to control all documents that are required by the QS regulation, as required by 21 C.F.R. § 820.40; For example,. your firm does not have procedures, for approving documents and for changing documents.
11. Management with executive responsibility has failed to ensure that an adequate quality system, has been fully implemented and maintained at all levels of your organization, as required by 21 C.F.R. § 820.20. For example, management has not documented whether it has appointed a management representative who has authority over and responsibility for the quality system, as required by 21 C.F.R. § 820.20(b)(3). Also, there are no established. procedures for management review of the quality system, as required by 21 C.F.R. § 820.20(c). No management reviews have been conducted prior to FDA's most recent inspection of your firm.
Our inspection also revealed that your devices are misbranded within the meaning of Section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm failed to submit a list for the Michigan Cranial Helmet and the Cranial Adjustive Prosthesis devices as required by Section 510(j) of the Act, 21 U.S.C. § 360(j) and the Device Listing Regulation, 21 C.F.R. § 807.20(a)(2). If you believe you have listed your devices with the FDA, please provide your documentation to FDA for review.
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 FDA 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.
We received a response from you, dated June 25, 2007, concerning our investigator's observations. However, your response did not address the FDA-483 or your plan for corrections.
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: Paige E. Wilson, Compliance Officer, at the above address. If you have any questions about the content of this letter please contact Ms. Wilson at (313) 393-8250.
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, 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.
Joann M. Givens
Detroit District Office