Care Diagnostica GmbH 4/23/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Sliver Spring, MD 20993
April 23, 2013
VIA UNITED PARCEL SERVICE
Dr. Kim Scheuringer
Care Diagnostica GmbH
Dear Dr. Scheuringer:
During an inspection of your firm located in Moellesrsdorf, Austriaon December 10, 2012 through December 13, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures IVD Test Kits. 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:
Your firm’s response dated January 25, 2013 to the Form FDA 483 (FDA 483) was not reviewed because it was not received within fifteen business days of issuance of the FDA 483. The response will be evaluated along with any other written material provided in response to the violations cited in this Warning Letter. These violations include, but are not limited to, the following:
1. Failure to establish and maintain adequate procedures for implementing Corrective and Preventive Action (CAPA) as required by 21 CFR 820.100(a).
For example, your firm has not established and documented CAPA procedures to ensure that quality problems are adequately investigated. The investigator requested your firm’s CAPA procedure and was informed your firm did not have a CAPA procedure. This is a (b)(4).
2. Failure to ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed and installed to facilitate maintenance, adjustment, cleaning, and use, as required by 21 CFR 820.70(g).
For example, your firm did not have validation records for the following manufacturing equipment: (b)(4). Your firm added the above pieces of equipment since the previous inspection and your firm was unable to provide validation records for the above manufacturing equipment. Your firm has been cited for this observation in a past inspection on a different device.
3. Failure to maintain records of changes to documents, as required by 21 CFR 820.40(b).
For example, during review of your firms design controls, your firm was asked if they had a Document Change Control Procedure and Change logs covering (b)(4) and (b)(4). Your firm provided QE04-07, a change control (b)(4) and stated you do not keep any document changes.
4. Failure to establish and maintain procedure to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed, as required by 21 CFR 820.250(b).
For example, sampling plans are not established and documented and are not based on valid statistical rational. The investigator noted during review of your firms’ DHR for finished products and incoming goods, that no matter how large the quantity of finished goods or incoming raw materials are, your firm only selects (b)(4) devices for inspection. Your firm was asked why only (b)(4) devices are inspected and Mrs. Claudia Handler, your firm’s Quality Assurance Manager, stated that there is no statistical basis behind this (b)(4).
Given the serious nature of the violations of the Act, IVD Test Kits manufactured 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 may take steps to refuse these products, 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 violation(s) 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 Ave., Silver Spring, MD 20993. Refer to CMS case #395007 when replying. If you have any questions about the contents of this letter, please contact: James Woods at 301-796-6225.
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.
Office of In Vitro Diagnostics
And Radiological Health
Center for Devices and