| Public Health Service Food and Drug Administration |
| 10903 New Hampshire Ave. Silver Spring, MD 20993-0002 |
Department of Health and Human ServicesFEB 25 2011
WARNING LETTER
Via United Parcel Service
Mr. Mats Lindgren
General Manager
Cenova Innovation and Productions AB
4, Florettgatan
SE-595 43 Mjolby,
Sweden
Dear Mr. Lindgren:
During an inspection of your firm located in Mjolby, Sweden, on September 13-15, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a contract manufacturer and packager for class II and III medical devices. The subject device is the “CoreTherm” System Microwave Thermotherapy for Benign Prostatic Hyperplasia (P010055/S006). 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.
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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from you, dated September 20, 2010, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. 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 establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
Specifically, Corrective and Preventive Action Procedure 3-9900-040, rev. 5, dated December 12, 2008, does not contain adequate provisions to:
1.) Analyze quality data (e.g., complaints and nonconformances/internal deviations) with appropriate statistical methodology where necessary to detect recurring quality problems; and
2.) Ensure corrective actions are verified or validated to ensure that such action is effective and does not adversely affect the finished product (e.g., Internal Deviation Nos. 111 and 349)
The adequacy of the firm’s response, dated September 20, 2010, cannot be determined at this time. You stated that the Corrective and Preventive Action Procedure 3-9900-040 would be updated with requirements for statistical analysis, investigations, and documentation no later than October 30, 2010. However, documentation has not been provided to show the update.
2. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a).
Specifically, Corrective and Preventive Action Procedure 3-9900-040 rev. 5, dated December 12, 2008, does not contain adequate provisions to ensure:
1.) Nonconformances are adequately investigated (e.g., Internal Deviation 310 and 181); and
2.) Persons or organizations responsible for nonconformances are notified of the nonconformances (e.g., Internal Deviation 310)
The adequacy of your firm’s response, dated September 20, 2010, cannot be
determined at this time. You stated that the Corrective and Preventive Action Procedure 3-9900-040 would be updated with requirements for investigations and documentation no later than October 30, 2010. However, documentation has not been provided to show the update.
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, batch number (b)(4) was reworked when returned from your customer due to a weld nonconformance. You did not establish a rework procedure for reworking and repackaging this lot. The reworked lot was mislabeled and returned to your firm's customer. The customer returned the lot a second time due to mislabeling.
The adequacy of your firm’s response, dated September 20, 2010, cannot be determined at this time. You stated that a procedure for rework will be created no later than October 30, 2010. However, no documentation has been provided to show the procedure for rework. Additionally, your firm has not informed FDA of any specific plan or provided evidence addressing global systemic corrective actions for rework of nonconforming products.
4. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
Specifically, Corrective and Preventive Action Procedure 3-9900-040 rev. 5, dated December 12, 2008, (used for handling complaints) does not contain provisions to ensure complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications are adequately investigated. Four of eleven customer complaints reviewed (Complaint Nos. 251, 246, 230, and 180) were not fully investigated and/or documented.
The adequacy of your firm’s response, dated September 20, 2010, cannot be determined at this time. You stated that the Corrective and Preventive Action Procedure 3-9900-040 would be updated with requirements for investigations and documentation no later than October 30, 2010. However, documentation has not been provided to show the update.
5. Failure to adequately document revalidation activities when changes or process deviations occur, as required by 21 CFR 820.75(c).
Specifically, inspections and tests (visual, pull, and dye penetrant) were conducted to support a change in the weld time for a validated packaging process and were summarized in a test report dated June 21, 2010. The source data used to generate the test report were not documented or maintained.
We have reviewed your response, dated September 20, 2010, and have concluded that it is inadequate because it does not adequately address the requirements of 21 CFR 820.75(c), nor has your firm provided the FDA with evidence of immediate corrections and systemic corrective actions. You stated that the root cause was due to negligence of the tester and that all staff making tests and validation would be retrained in the requirement of always saving data. Although you plan to retrain the staff, you have not addressed a global systematic approach to Change Control Procedure 3-9900-024.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action, which may include detaining your devices without physical examination upon entry into the United States until the corrections are completed. Section 801(a) of the Act (21 U.S.C. § 381(a)). Also, U.S. federal agencies are advised of the issuance of all 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 (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. If the documentation is not in English, please provide a translation to facilitate our review.
Your response should be sent to: Paul Tilton, 10903 New Hampshire Avenue, WO-66, Room 3540, Silver Spring, Maryland 20993. If you have any questions about the content of this letter please contact: Paul Tilton 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 facility. It is your 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 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Sincerely yours,
/S/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health
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