Amigo Mobility International, Inc 5/21/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Detroit District 300 River Place Suite 5900 Detroit, MI 48207 Telephone: 313-393-8100 FAX: 313-393-8139

Warning Letter
2010-DT-12

May 21, 2010

VIA UPS

Beth L. Thieme
Vice President and CEO
Amigo Mobility International, Inc.
6693 Dixie Highway
Bridgeport, Michigan 48722

Dear Ms. Thieme:

During an inspection of your firm located in Bridgeport, Michigan on December 16, 2009 through January 15, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Amigo Escort 7.5 Active Lifestyle by Amigo, Amigo RD and Amigo RT Express. 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. Failure to establish and maintain procedures to control the design of a device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30.

For example: You have not developed any design control procedures or documented any design control activities performed for the design of the Amigo Escort 7.5, Amigo RD, or Amigo RT Express devices.

2. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100.

For example: Though you have developed (b)(4)"Corrective and Preventive Action", the procedure does not ensure that all requirements under 21 CFR 820.100 will be met, you have never initiated any CAPAs, and you indicate that (b)(4) is not currently in use.

3. Failure to establish and maintain adequate procedures to control product that does not conform to specified requirements which should ensure that the evaluation of nonconformances shall include a determination of the need for an investigation, as required by 21 CFR 820.90(a).

For example: Nonconformance Reports (b)(4) through (b)(4) and (b)(4) do not contain any determination of the need for an investigation or rationale for not performing an investigation.

4. Failure to establish and maintain a complaint procedures that ensure complaints are effectively received, reviewed and evaluated by a formally designated unit, as required by 21 CFR 820.198(a).

For example: You have not documented any complaints since 11/14/2002 despite the fact that complaints have been received, such as MDR 1821729-2005-00001, and Amigo Work Orders dated 2/24/2009,7/8/2009, and 8/13/2009.

5. Failure to maintain device master records (DMR's), as required by 21 CFR 820.181. For example: You manufacture product using only drawings and have not established any of the other required elements of a DMR (such as production process specifications) for any of the devices you manufacture.

6. Failure to establish adequate procedures for quality audits to assure 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 CFR 820.22.

For example: Though you have created procedure (b)(4) "Internal Audits" you have never documented an internal audit.

7. Failure to ensure that management with executive responsibility review the suitability and effectiveness of the quality system at defined intervals, as required by 21 CFR 820.20(c).

For example: Though (b)(4) "Management Responsibility" section (b)(4) requires (b)(4)

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: Catherine V. Quinlan, Compliance Officer, Food and Drug Administration at 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions about the content of this letter please contact Mrs. Quinlan at (313) 393-8153 or by facsimile at (313) 393-8139.

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.

Sincerely,

/s/

 

Joann M. Givens
District Director
Detroit District Office

 

 

 

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