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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993-0002
June 6, 2013
VIA UNITED PARCEL SERVICE
Mr. Johan Janssens
Chief Operations Officer
Dear Mr. Janssens:
During an inspection of your firm located in Hasselt, Belgium on January 21, 2013, through January 24, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Spirotome (biopsy instruments). 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 to affect the structure or function of the body.
Our inspection revealed that your firm’s devices are 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 devices that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 CFR Part 803 - Medical Device Reporting.
These violations include, but are not limited to, the following:
Failure to develop, maintain, and implement MDR procedures, as required by 21 CFR Part 803.17. For example, you reported that the firm did not have any MDR procedures.
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 award 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 (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. Please provide a translation of documentation not in English to facilitate our review.
In addition, FDA has noted nonconformances with regards to section 501(h) of the Act, (21 U.S.C. § 351(h), which are deficiencies within 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 nonconformities include, but are not limited to, the following:
1. Failure to establish and maintain adequate procedures to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications as required by 21 CFR 820.70. For example:
a. The (b)(4) (procedure (b)(4)) does not define how often the (b)(4).
b. The (b)(4) (procedure (b)(4)) does not define how often the (b)(4).
c. The procedure for (b)(4).
d. Procedure (b)(4) does not define how often (b)(4). This is where devices are (b)(4).
2. Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d). For example, the acceptance testing performed on the finished devices is not documented in a procedure and not listed in the device history records. The testing/inspection performed was not documented in any device history record.
3. Failure to establish and maintain adequate procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example, (b)(4) device history records reviewed did not document any non-conforming products. The quality control history documents the number of nonconformance for those lots, but there is no documentation on the disposition of the nonconforming product. (b)(4) device history records reviewed that documented nonconformance did not include disposition and retesting of rework.
4. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, (b)(4) corrective actions reviewed were incomplete and not implemented.
5. Failure to establish and maintain adequate procedures for validating the device design, including software validation and risk analysis, where appropriate, as required by 21 CFR 820.30(g). For example, your firm did not include all medical devices manufactured and (b)(4) sterilized. Your firm established a procedure for (b)(4) load sizes for each device type, but no evidence to support the load sizes was documented.
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 Operations Branch, White Oak Building 66, Room 2609, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993. Refer to the CMS case # 396903 when replying. If you have any questions about the contents of this letter, please contact Debra Demeritt at 301-796-5770.
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, Form 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