Production workers at ATS Manufacturing threw out all of the nonconforming products they found and failed to document any follow-up activities over the course of nearly four years, an FDA investigator discovered in an August 14-18 inspection.
In a Form 483 report, the FDA official listed inadequate procedures for controlling nonconforming products among 10 inspection observations at the medical device manufacturer’s facility in Elkhart, Indiana.
Between October 2014 and August 2017, production workers said they had been scrapping all nonconforming products they identified but documentation of this activity could not be found during the inspection.
The facility also lacked documentation for inspection of raw materials since January 2015, and many required device history records.
The investigator also identified problems in calibrating and maintaining equipment. The firm’s calibration log revealed that the last calibration was performed on Feb. 5, 2014 and the due date for the next calibration was listed as Feb. 5, 2015. The firm failed to document that maintenance had been done on any equipment since January 2015.
In addition, there was no evidence of any internal quality audit being performed at the facility since July 11, 2014, and management had yet to conduct a single review of the firm’s quality system.
Other nonconformities noted in the Form 483 report relate to process validation, CAPA procedures, as well as monitoring and controlling process parameters.
For example, the firm failed to provide evidence that the quality data sources in a CAPA procedure had been documented between Jan. 1, 2015 and Aug. 14, 2017, or analyzed to determine whether a correction action was needed.
Read the ATS Manufacturing Form 483 here: www.fdanews.com/11-09-17-atsmanufacturingllc483.pdf.
How to Build a Better Internal Audit
The annual internal audit can be considered the devicemaker’s front-line defense against 483 observations, warning letters and other enforcement actions. As such, it needs to be carefully designed, targeted to specific goals and fully supported by management.
Four common mistakes keep showing up on 483s and warning letters. One of the most common citations is companies using internal auditors who have direct responsibility over the area they are reviewing. For instance, if complaint handling falls under the purview of the quality systems manager, that individual should not audit the complaint handling process. Independence of the auditors is a requirement under 21 CFR Part 820, the Quality System Regulation (QSR).
Another common citation is for companies that don’t do internal audits at all, or don’t do them with sufficient frequency, which for the FDA means at least once a year.
Failure to establish procedures for internal audits, along with the related citations of failing to establish adequate procedures or failing to follow written audit procedures, are a third common citation in 483s and warning letters. Devicemakers need to have a document that states what they will do regarding internal audits and then follow those procedures.
The fourth top citation is failure to adequately document audit findings. It doesn’t matter how well a company may have conducted an audit or followed its audit procedures if there is no documentation of that fact. Documentation procedures should be included in the overall audit procedures and followed scrupulously.
Excerpted from the FDAnews report: Effective Internal Audits and Quality Control Units for Devicemakers.