- AGFA Healthcare Corp.
- Issuing Office:
- Atlanta District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Atlanta District Office|
60 Eighth Street N.E.
Atlanta, GA 30309
September 30, 2014VIA UPS
Christian Reinaudo, CEO
AGF A Healthcare NV
2640 Mortsel, Belgium
Dear Mr. Reinaudo:
During an inspection of AGF A Healthcare Corporation, conducted at 10 S. Academy Street, Greenville, SC 29601 on March 3 - April 11, 2014, an investigator from the U.S. Food and Drug Administration (FDA) determined that your firm manufactures various medical devices such as the DX-D100 X-Ray machine. These products are devices within the meaning of Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) § 321(h)] in that 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) regulations found at Title 21 of the Code of Federal Regulations Part 820 (21 CFR Part 820).
A FORM FDA 483, Inspectional Observations, was issued to Phil Cuscuna, Director of QA/RA Americas (copy enclosed for your review). We have received your firm's response letter dated May 01, 2014, concerning our investigator's observations identified on the FDA 483. We address these responses below, in relation to each of the noted violations. The violations documented on the FDA 483 issued include, but are not limited to, the following:
1. Corrective and preventive action activities and/or results have not been adequately documented as per, 21 CFR 820.100(b). Specifically,
a. Your firm has failed to adequately correct and prevent recurring problems. For example, Customer calls associated with Issue No. HQ_1206130003 opened 6/13/2012 in which the system fails to reprocess updated information (polling) due to entry of unsupported time format. Corrective actions to correct the issue have not been taken and the firm continues to receive complaints for this issue (e.g. PC1312070096 created 12/7/2013; PC1401150478 created 1/15/2014; and PC1402110216 created 2/11/2014). The Problem Record remains outstanding with corrective action "TBD".
In your response letter dated, 05/01/14, you indicate that on August 30, 2012, "Agfa implemented a software update (SU) of the monitoring function of IMPAX CV 7.8 to alert a user if this issue occurs. While this notification mitigates the potential risk of patient harm from the lack of polling, Agfa has not yet identified a permanent correction to prevent this issue from occurring". Furthermore, your response indicates "To further mitigate any residual risk, by May 15, 2014, we will notify all potentially affected customers that this issue remains outstanding and that Agfa is working to develop a solution." Additionally, your response indicates that Agfa intends to develop software that will resolve this specific issue by the end of 2014. Please provide our office with additional details on how this software will correct this recurring issue and the current status of your corrective actions.
b. Customer calls associated with HQ_1202150005 identifying the loss of images due to wrong configuration of DICOM store were initially received in February 2011. The Problem Correction Plan included the notification of all customers via Urgent Safety Notice in August 2012 of a Hotfix and re-configuration to eliminate this event was conducted at customer sites in Q4 of 2013. As of February 2014 the firm continues to document calls on this issue (SR130930013 created 2/6/2014 and PC1312160043 created 1/6/2014).
In your response letter, you indicate that your firm will review customer sites to identify any remaining previous occurrences in the field and that your firm will then correct each of these issues on a case-by case basis. Furthermore, your response indicates that the analysis of your customers will be completed by December 31, 2014. Please provide our office with an update status of your corrective action for this observation.
2. Complaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated, and investigated where necessary as required by 21 CFR 820.198( c). Specifically, complaints are not investigated and closed in a timely manner. Approximately 691 complaints remain open from 2013 and 1071 complaints are open at the end of Feb 2014.
Your response letter indicates that you will review the complaints cited in this observation that has been open for more than 90 days and that this review will be completed by June 15, 2014. You indicate that your firm will modify its procedures and retrain relevant personnel by July 31, 2014. Additionally, you indicate that your firm will evaluate and improve the operation of its entire product complaint lifecycle by December 31, 2014. We request that your firm provide an updated status report regarding your corrective actions related to this observation.
3. Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been established in accordance with 21 CFR 820.70(a). Specifically, process procedures for re-furbishing DX-D100 x-ray machines are incomplete in that procedures do not include all of the steps necessary for the re-furbishing process. For example, there are no inspection requirements for the returned unit and the current procedures do not allow for a quality review of repaired, used DX-D100 devices prior to the final release.
Your response letter indicates that your firm will discontinue all refurbishment activity for the DX-D100 until you have revised your procedures for repairing DX-D100 units to require quality assurance oversight over refurbishment activities. Additionally, you indicate that on April 22, 2014, your firm conducted a retrospective review of the data and testing that Agfa conducted on the refurbished DX-D100 machines. Your review concluded that there were no issues relating to the safety or efficacy of these units. However, Attachment 11 provided in your response letter, fails to adequately describe the criteria used by your firm to determine that there were no issues relating to the safety or efficacy of these units. Our office requests that you provide additional details regarding the criteria used by your firm during your retrospective review.
Our inspection also revealed that the DX-D110 X-ray machine and IMPAX CV Reporting 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 regarding the device that is required by or under Section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant deviations include, but are not limited to:
1. Failure to report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets malfunctioned and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).
Complaints PC 1305170355, PC1305310251 and PC 1403030427, describe malfunctions of your firm's DXD110 X-ray machine (device moving on its own, lurching forward, and motion problem, respectively). The result of your firm's evaluation of these complaints indicates that the actual risk or potential risk associated with the malfunctions is "Potential Death". Without additional information that rules out that the referenced malfunctions would not be likely to cause or contribute to a death or serious injury, the limited information included for the complaints reasonably suggests that the malfunctions would be likely to cause or contribute to a death or serious injury if the malfunctions were to recur. The MDRs were not received by the FDA within the required 30 calendar day timeframe.
Complaint HQ 1105270003 contains information about two events describing a malfunction of the IMPACX CV Reporting (misconfiguration of outbound product) that resulted in the patient receiving the wrong treatment based on misattributed report and interchanging patient identification and results (demographics and results) from the report. Your firm submitted two MDRs for these events, numbered 1225058-2012-00008 and MDR 1225058-2012-00009. The MDRs were not received by the FDA within the required 30 calendar day timeframe.
Complaint HQ_1005180007 describes a malfunction of the IMPACX CV Reporting (nonsupport of compound sentences) that is associated with recall Z-2112-2010. Your firm submitted an MDR for the event, numbered 1225058-2013-00935. The MDR was not received by the FDA within the required 30 calendar day timeframe.
Complaint PR 1401240009 contains information about six events describing a malfunction of the IMPACX CV Reporting (misapplication of the hotfix) that resulted in misappropriating the weight field to the height field and leaving the weight field blank for pediatric patients. Your firm submitted six MDRs for these events, numbered 1225058-2014-00003, 1225058-2014-00004, 1225058-2014-00005, 1225058-2014-00006, 1225058-2014-00007, and 1225058-2014-00008. The MDRs were not received by the FDA within the required 30 calendar day timeframe.
We reviewed your firm's response dated May 1, 2014, and conclude that it appears to be adequate. Your firm stated that it redesigned the complaint handling system; submitted additional MDRs; and trained personnel.
The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirements of this final rule will take effect on August 14, 2015. If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements: http://www.fda.gov/Forlndustry/FDAeSubmitter/ucm107903.htm
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, 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 our 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.
Your firm's response should be sent to: Derek Price, Compliance Officer, Atlanta District Office, 60 Eighth Street NE, Atlanta, Georgia, 30309. If you have any questions about the contents of this letter, please contact: Compliance Officer Price by phone at (404) 253-2277 or by fax at (404) 253-1201.
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.
Atlanta District Office
Phil Cuscuna, Director of QA/RA Americas
AGF A Healthcare Corp.
10 S. Academy Street
Greenville, SC 29601