Inspections, Compliance, Enforcement, and Criminal Investigations

Enraf-Nonius B.V. 7/5/13


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 10993 


July 5, 2013
Len de Jong
Chief Executive Officer
Enraf-Nonius B.V.
Vereseweg 127
Rotterdam, Netherlands
Dear Mr. de Jong:
During an inspection of your firm located in Rotterdam, Netherlands, on March 25, 2013, through March 27, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures motorized tables, ultrasound therapy, and diathermy 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 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.  These violations include, but are not limited to, the following:
1.    Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a).  For example:
a.  Your firm failed to establish predetermined acceptance criteria for validation activities conducted at clinical sites for the Sonopuls 190. Additionally, your firm failed to document the location of the sites that were to be used.
b.  Your firm’s design change procedure, EN114, (b)(4) fails to include steps to determine whether design changes require validation or verification, prior to implementing a design change, and the documentation of such assessment.
c.  Your firm failed to document post-production design verification to changes made to the (b)(4).  The verification of 10 units tested in the field did not have documentation on how the testing was to be conducted, the acceptance criteria, and the dates and locations of the testing.
d.  Verification activities failed to confirm whether design inputs met design outputs.  Specifically, test method, pre-determined acceptance criteria, and data were not included in the following tests:
i.  LCD backlight testing
ii.  Serial communication
iii.  Frequency generation
iv.  User input and graphical output testing
v.  Pulse frequency
vi.  Duty cycle; and
vii.  Treatment duration
2.    Failure to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results, as required by 21 CFR 820.72(a).  For example, your firm’s design verification procedure does not require that test equipment and software are fully validated, as needed, and prior to use in design verification activities.
3.    Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). For example, your firm’s CAPA procedure fails to include a process that ensures corrective actions identified within the CAPA investigation include actions to prevent the situation from reoccurring.  Specifically, CAPA D10034 was opened due to an external audit finding of illegible, missing, or incorrect component codes.  However, CAPA D10034 did not include actions needed to prevent this nonconformance from reoccurring. Additionally, this CAPA procedure is only used to address issues identified during internal and external audits.
4.    Failure to document CAPA investigation activities as required by 21 CFR 820.100(b).  For example, your firm failed to document, as required by procedure 004-09, “Corrective and Preventive Action Procedure,” Revision 005, the effectiveness of the corrective and preventive actions described in CAPA D10034.
5.    Failure to investigate a complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications, as required by 21 CFR 820.198(c).  For example:
a.  Complaint SV/1027 was received on March 14, 2012, for the Sonopuls 190 device, which alleged problems with the ultrasonic treatment head.  The treatment head was sent to the Rotterdam facility for analysis.  However, there was no documentation of this analysis or any other testing that may have been conducted.
b.  Complaint AS/1002 was received on June 13, 2012, for two ManuXelect motorized tables, which alleged that the motors did not work.  As a result, two replacement motors were sent to the customer.  However, no further investigation into the failure was documented.
Given the serious nature of the violations of the Act, motorized tables, diathermy, and ultrasound therapy devicesmanufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated.  As a result, FDA is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are corrected.  In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter.  We will notify you if your firm’s response appears to be adequate, and we may need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
Also, U.S. 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. 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 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, including 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.  Please provide a translation of documentation not in English to facilitate our review.
Your firm’s response should be sent to:
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Field Operations Branch
White Oak Building 66, Rm 2609
10903 New Hampshire Avenue
Silver Spring, MD 20993
Refer to the Unique Identification Number 398439 when replying.  If you have any questions about the contents of this letter, please contact:  Matthew C. Krueger at
301-796-5585 or via fax at 301-847-8138.
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. 
Sincerely yours,
Steven D. Silverman
Office of Compliance
Center for Devices and Radiological Health
Cc:  Mr. Robert Punt
U.S. Agent
3100 NW Bucklin Hill Road
Suite 116
Silverdale, WA 98383

Page Last Updated: 07/11/2013
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