The FDA has released a warning letter recently sent to DePuy Orthopaedics, a division of Johnson & Johnson, in which the agency identified fourteen devices and related components being manufactured at the company’s Warsaw Indiana location as “adulterated” under applicable regulations because DePuy does not have approved applications for premarket approval (PMA) in effect, or approved applications for investigational device exemptions (IDE). (Rottenstein Law group post)
Inspections, Compliance, Enforcement, and Criminal Investigations
DePuy Orthopaedics, Inc. 12/8/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
Ms. Mary E. Riggs
World Wide VP Finance
DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
Dear Ms. Riggs:
During an inspection of your firm located in Warsaw, Indiana, on May 10, 2011, through June 7, 2011, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the ASR Acetabular Cup System, ASR XL Acetabular Cup System, Pinnacle Acetabular System, PFC Sigma Knee System, Agility LP Total Ankle Prosthesis, and other ankle, knee, hip, shoulder, elbow, and wrist replacement devices. 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.
SCP-905 also indicates that up to (b)(4) identical devices can be manufactured and still be considered a “custom device” by your firm. The standard for a custom device does not include a quantitative limit or quantitative allowance.
In addition, SCP-905 does not ensure that the devices at issue are not generally available in finished form or to other physicians, as is required to meet the custom device definition.
Thus, none of the devices listed above constitute a custom device. These devices do not deviate from generally available devices or from applicable performance standards, and they have common, standardized design characteristics, chemical and material compositions, or manufacturing processes. Although the devices' size and shape may vary with each patient’s anatomy, the standardized design characteristics do not vary among the devices manufactured. The fact that final specifications are tailored to match a patient’s anatomy does not preclude a clinical study or submission of a marketing application for the devices.
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/or 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 awarding of contracts.
A follow up inspection will be required to assure that corrections and/or corrective actions are adequate.
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 (including any systemic corrective actions) 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.
In addition, FDA notes the following concerns regarding your firm’s compliance with the Quality System (QS) regulation requirements found at 21 CFR Part 820:
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 Inspectional Observations, 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.
Steven D. Silverman
Office of Compliance
Center for Devices and Radiological Health