Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Kansas City District|
11630 West 80th Street
Lenexa, Kansas 66214
Telephone: (913) 752-2100
January 9, 2012
RETURN RECEIPT REQUESTED
Ref. KAN 2012-04
Mr. Dennis E. Clark, President
Orthotics & Prosthetics One Inc.
527 Park Lane, Ste 200
Waterloo, IA 50701
Dear Mr. Clark:
During an inspection of your firm located in Waterloo, IA on November 29 through December 1, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures lower limb prosthetics. 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.
While these devices may be customized to fit the individual recipient, they do not meet the definition of a custom device. These devices are classified as Class II medical devices as stated in 21 CFR 890.3500. These devices are exempt from premarket notification. However, they are not exempt from the current good manufacturing practice (CGMP) requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
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 CGMP requirements of the Quality System regulation found at Title 21, CFR, Part 820. These violations include, but are not limited to, the following:
1. Failure to establish a quality plan as required by 21 CFR 820.20 (d). For example, during your firm's inspection, you acknowledged that a quality plan had not been established.
2. Failure.to establish quality system procedures and instructions as required by 21 CFR 820.20 (e). For example, during your firm's inspection, you acknowledged that quality system procedures and instructions had not been established.
3. Failure to establish a quality policy and quality objectives as required by 21 CFR 820.20 (e). For example, during your firm's inspection, you acknowledged that a quality policy and quality objectives had not been established.
4. Failure to perform quality audits as required by 21 CFR 820.22. For example, during your firm's inspection, you acknowledged that quality audits had not been performed.
5. Failure to establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements as required by 21 CFR 820.50. For example, during your firm's inspection, you acknowledged that purchasing or receiving procedures had not been established.
6. Failure to establish a device master record as required by 21 CFR 820.181. For example, during your firm's inspection, you acknowledged that a device master record had not been established.
7. Failure to establish design plans that describe or reference the design and development activities and define responsibility for implementation as required by 21 CFR 820.30 (b). For example, during your firm's inspection, you acknowledged that design plans had not been established.
8. Failure to establish document control procedures as required by 21 CFR 820.40. For example, during your firm's inspection, you acknowledged that document control procedures had not been established.
9. Failure to establish procedures for corrective and preventative action as required by 21 CFR 820.100 (a). For example, during your firm's inspection, you acknowledged that corrective and preventative action procedures had not been established.
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 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 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 your firm receives this letter of the specific steps you have taken to correct the noted violations, as well as an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions 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 these 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.
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 firm's 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 management systems. Your firm should investigate and determine the causes of the violations, and take prompt action to correct the violations and to bring your products into compliance.
Please send your response to Danial S. Hutchison, Compliance Officer, at the above address. If you have any questions about the content of this letter, please contact Mr. Hutchison.
John W. Thorsky
Kansas City District