Inspections, Compliance, Enforcement, and Criminal Investigations
Macan Engineering and Manufacturing Company Inc. 15-Sep-05
Department of Health and Human Services
Public Health Service
September 15, 2005
RETURN RECEIPT REQUESTED
Ms. Ruth Andris, Owner
Macan Engineering and Manufacturing Company Inc .
1564 North Damen Avenue
Chicago, IL 60622-1942
Dear Ms. Andris:
During our inspection of your firm from June 21 to June 27, 2005, United States Food and Drug Administration (FDA) investigators determined that your firm manufactures electrosurgical instruments for human dental surgery and veterinary surgical use. These products are devices as defined by Section 210(h) of the Federal Food, Drug, and Cosmetic Act (the Act).
The Act requires distributors of medical devices to obtain marketing clearance for their products from the FDA before they offer them for sale. This helps protect the public health by ensuring the new devices are safe and effective or substantially equivalent to other devices already legally marketed in this country.
You do not have marketing clearance or approval from FDA for the following two products: Macan MC4A and MC6. Your distribution of these instruments is in violation of the law. These devices are adulterated under Section 501(f)(1)(b) of the Act [21 U.S.C. 351 (f)(1)(b)], because you did not obtain premarket approval prior to marketing them. These instruments are also misbranded under Section 502(o) of the Act [21 U.S.C.352(o)], in that the manufacturer has not provided notice of intent to market these devices.
This inspection revealed that your device, Macan MC6A, is misbranded within the meaning of Section 502(a) of the Act [21 U.S.C. 352(a)], in that the labeling is false or misleading. The Macan MCGA power output specifications listed in the operating manual being shipped with the devices are different from the specifications stated on the firm's 510(k).
The recent inspection also revealed that your 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 in their manufacturing, packing, storage, or installation are not in conformance with the Quality System Regulation (QSR), Title 21, Code of Federal Regulations (CFR), Part 820, as follows:
1. Your firm failed to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a).
2. Your firm failed to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
3. Your firm failed to implement procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, and complaint files are not being maintained, as required by 21 CFR 820.198(a).
4. Your firm failed to establish and maintain procedures to ensure that device history records for each batch lot or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record and the quality system regulations, as required in 21 CFR 820.184.
5. Your finn failed to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.
6. Your firm failed to establish procedures for identifying training needs and document training, as required by 21 CFR 820.25(b).
7. Your firm's management with executive responsibility failed to appoint, or document such appointment, of a member of management, who irrespective of other responsibilities, shall have authority for ensuring that quality system requirements are effectively established and effectively maintained in accordance with 21 CFR Part 820 (Quality System Regulation) and reporting on the performance of the quality system to management with executive responsibility for review, as required by 21 CFR 820.20(b)(3).
8. Your finn failed to establish how quality planning will be met, as required by 21 CFR 820.20(d).
9. Your firm failed to control your labeling and packaging operation to provide proper identification and prevent mix-ups, as required in 21 CFR 820.120(d).
10. Your firm failed to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required in 21 CFR 820.30(a).
11. Your firm failed to establish and maintain procedures for the identification, documentation, validation, review and approval of design changes before their implementation, as required in 21 CFR 820.30(i).
12. Your firm failed to establish and maintain, where deviations from device specifications could occur as the result of the manufacturing process, process control procedures that describe any process controls necessary to ensure conformance to specifications, as required by 21 CFR 820.70(a).
This letter in not intended to be an all inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the Form FDA-483, List of Inspectional Observations, issued at the conclusion of the inspection may be symptomatic of serious underlying problems in your establishment's quality system.
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 contacts. No premarket submissions for Class III devices, to which the QSR deficiencies are reasonably related, will be cleared or approved 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 and verified.
You should take prompt action to correct these deviations and to establish procedures to prevent their recurrence. Failure to promptly correct these deviations may result in regulatory action being initiated by FDA without further notice. These actions include,but are not limited to, seizure, injunction, and /or civil penalties.
FDA acknowledges your response to the Form FDA-483, dated July 27, 2005. FDA has determined this response to be inadequate, as you have failed to provide evidence of implementation, or a finalization date, for the draft procedures that you offered in response to Observations 1, 3, 4, 5, 7, 9, 10 and 13 and 16. In addition, you have failed to provide a documented design change procedure that was followed to make the design change referenced in your response to Observation 8, and you did not explain why the devices containing the serial numbers that did not meet specifications that are referenced in your responses to Observations 11 and 12 were distributed. You failed to provide any response to Observations 13-15. Your responses to Observations 2 and 6. however, may be adequate if there is verification that these changes have been implemented.
Please notify this office, in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including (1) the time frames within which the corrections will be completed, (2) any documentation indicating that 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 ensure that similar violations will not occur.
Your response should be sent to Matthew Sienko, Compliance Officer. If you have any questions regarding this letter, please contact Mr. Sienkco at (312) 596-4213.
Scott J. MacIntire