USFDA inspected Phillips Medical Systems 7-17 to 8-18, 2017 and on completion of the inspection issued Phillips Medical Systems an 18 page 483 with 9 observations.
If I were a patient and had to get re-scanned/re-injected because of a known equipment failure (page 3, b1) , I would be a bit upset. Or as identified on Page 7, C1, where “Brain CT data exhibited ring artifact which were initially misinterpreted as a brain hemorrhage“, this would cause a bit of concern.
I would recommend reading the entire 483 as the focus of the inspection was on complaint handling (observation 1), complaint handing procedures (observation 2), CAPA (observation 3), risk analysis (observation 4), purchasing controls (observation 5), incoming acceptance sampling (observation 6), process controls (observation 7), design changes (observation 8) and MDR (observation 9). A host of good information to learn from other people’s citations. A summary of information from the first three observations is excerpted in this blog post:
Observation 1 is listed in the Annotations to Observation section as under consideration. However, in this observation address inadequate investigation of complaints. As detailed, in the 483:
Out of 133,845 complaints received from July 2016-July 2017, 129,736 complaints were closed based only on the assigned HHM (hazard/harm) symptom code and not further investigated (97%). From January 2016 to present, there were 3,623 complaints (representing 33 HHM symptom codes) that received a low HHM severity level of [redacted] (less than moderate or no injury), but had a high RMM (risk matrix) severity level of [redacted] (potential serious injury or [redacted] potential death).
Of these 3,623 complaints, 1,792 should have been escalated based upon your “Service Record Reviewer Team (SRRTI Monitoring Work Instruction”, #CNV-073105-01 and forwarded to the Complaint Handling Unit (CHU) for further investigation.
Additionally, a query of complaints from Feb 2014 to present for HMM codes related to rescan or reinjection of patients found that codes which meet the criteria for escalation are not always forwarded to the CHU.
An example complaint, page 3, item (b1) of the 483:
Ingenuity TF PET/CT imaging System: The user reported a reconstruction failure that resulted in a rescan and reinjection. The complainant stated that this is occurring monthly.
…Since the RMM was deemed “Acceptable”, the issue was not forwarded to CAPA and not assessed by your Product Safety Committee (PSC) for potential Correction or Removal. From l/22/2013 to present, you have received 22 complaints with the same failure mode.
Observation 2 addresses the firm’s complaint handling procedure. As detailed in the 483:
Your procedures for entering complaints do not describe how and when failure codes are entered during the complaint process. You do not have any procedure that defines these failure codes. During complaint processing, you enter a HHM symptom code for all complaints, but only enter a failure code for those complaints that are escalated to the Complaint Handling Unit (CHU). Therefore, you have not entered failure codes for the 97% of complaints received since January 2016 (129,736 complaints).
Observation 3 addresses the firm’s CAPA system, as identified in the 483:
Complaints and non-confo1mances (QNs & CTUDTs) are only evaluated for potential corrective/preventive actions when an escalation criteria is met. These criteria are incomplete & vague and do not ensure consistent escalation of your data sources.
An example of escallation criteria from page 6, item (a1) of the 483:
Item #2 of section 4.3.3 states that one reason to escalate is because of a “violation of an applicable regulation“, e.g: 21CFR820. Most of your data sources would appear to meet these criteria, but have not escalated to a CAPA.
Complaint handling is a requirement of the QSQ (21 CFR 820.198). in the 1978 Premble [4110-03, item # 134] to the GMP regulations state:
The Commissioner disagrees with the comments because complaints dealing with an injury deserve special attention when there is a possibility that the failure of a device is responsible for the injury. The Commissioner also believes that those complaints about a device’s identity, quality, durability, reliability, safety, effectiveness, or performance are often indicative of poor manufacturing practices requiring correction. In evaluating the adequacy and appropriateness of a quality assurance program, the Commissioner is interested in learning how a manufacturer investigates and follows up on such complaints.
To help assure that this investigation and followup occur, the Commissioner is amending the final regulation to require that a written record of each investigation of a complaint be maintained and be readily available at the manufacturing site in a file designated for device complaints. The Commissioner believes that this requirement will facilitate the effective enforcement of the act by assuring that complaint investigation reports are accessible to responsible company officials and to FDA representatives who, in turn, can determine whether necessary corrective action has been accomplished.
The Commissioner advises that FDA representatives will routinely examine a manufacturer’s complaint file to determine whether those complaints that require followup have been properly investigated.