- Stockert GmbH
- Issuing Office:
- Center for Devices and Radiological Health
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
APR 14, 2015
VIA UNITED PARCEL SERVICE
Chief Executive Officer
Boetzinger Strasse 72
79111 Freiburg Im Breisgau
Dear Mr. Nüdling:
During an inspection of your firm located in Freiburg Im Breisgau, Germany, on November 10, 2014,through November 13, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the radio-frequency (RF) SmartAblate System. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.
Our inspection revealed that the RF SmartAblate System is misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 – Medical Devices; Reports of Corrections and Removals.
We received a response from your firm, dated December 16, 2014, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to submit a Report of Correction or Removal for a medical device correction or removal initiated to reduce a risk to health or to remedy a violation of the Act caused by the device, which may present a risk to health, as required by 21 CFR 806.10.
For example, your firm initiated corrective and preventive action (CAPA) report 481, on September 22, 2011, in response to an increase in complaints for hardware errors on Electromagnetic Pulse radiofrequency generators. Your firm’s risk analysis, Risk Sheet #29, indicates potential for injuries or burns when the end users are unable to turn off the generator. Your firm replaced the power transistor with a new component to prevent a malfunction (loss of power) of the generators. However, this corrective action was not reported to the FDA.
Your firm’s response did not address this observation.
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.
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 (which must address systemic problems) 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 letter. Please provide a translation of documentation not in English to facilitate our review.
In addition, FDA has noted deficiencies with your firm’s quality system pertaining to current good manufacturing practice requirements specified in the Quality System regulation found at 21 CFR Part 820. These deficiencies include, but are not limited to, the following:
2. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). For example, on February 6, 2014, your firm conducted design verification and validation activities using pre-existing production units of irrigation pumps for the SmartAblate System, that were subsequently modified to reflect a new hardware version. However, your firm did not document the activities performed to modify the pump hardware.
3. Failure to establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications, as required by 21 CFR 820.90(b)(2). For example, internal orders (b)(4), (b)(4), (b)(4), (b)(4), and (b)(4) revealed test failures that required rework activities to be performed to bring the devices back into specification. However, your firm did not document the rework instructions. Your firm did not evaluate whether the rework had an adverse effect on the finished device.
4. Failure to establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product, as required by 21 CFR 820.90(b)(1). For example, your firm's nonconforming product procedure does not:
a. Describe the review and disposition process of nonconforming product.
b. Ensure the disposition of nonconforming product is documented.
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not provide documents in English in your response.
Your firm’s response to this letter should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Inspections Support Branch, White Oak Building 66, Rm. 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #446574 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch, at +1 (301)796-5587 or +1 (301) 847-8139 (fax).
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.
Jan B. Welch, MHS, MT (ASCP) SBB
Office of Compliance
Center for Devices and
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