FDA Dings Surgical Instrument Manufacturer Over 'Unacceptable' Timelines

American Contract Systems provided “unacceptable” timelines to correct US Food and Drug Administration (FDA) inspectional citations, according to a new FDA warning letter.
 
The Pennsylvania-based manufacturer of surgical trays and kits indicated for hospital use drew a total of five significant violations, following the quick turnaround on the warning letter. FDA investigators inspected the firm’s manufacturing facility in Zelienople over the course of two weeks from September through October. They revealed several nonconformities to good manufacturing practices (GMP), as the firm was subsequently further informed via a Form 483.
 
The firm’s 17 October response to the 483 included “unacceptable” timelines for three out of the five GMP buckets FDA deemed significant violations in the warning letter. These relate to inadequate validation processes and documentation as well as failures to monitor critical process parameters in routine sterilization operations and products undergoing sterilization to ensure conformity. Upkeep of device history records was also deemed inefficient by FDA.
 
The firm indicated to FDA that an independent review of device components as well as implementation of a new approach on critical process parameters and revised procedures to ensure a device conforms to specifications will not be completed until 31 March 2019. The timeline or timeframe set for these corrective actions were insufficient to ease FDA’s concerns.
 
“We request a timeline for when you plan to have revised procedures implemented to ensure that you are complying with 21 CFR 820.70(a),” the agency clarified. “We would also expect that you will be revising your device master records accordingly to ensure that they include, or refer to the location of, all device specifications, component specifications, and production process specifications, including bag size, as required by 21 CFR 820.181(a).”
 
The remaining violations cited in the warning include inadequate procedures for specification changes in sterilization processes and an inadequate organizational structure. The firm’s response to the former was inadequate in that it did not describe how future changes will be in compliance with current regulations. In reaction to the latter violation, FDA said the firm “has not provided an adequate structure of resources, including the assignment of a dedicated individual that is responsible for overseeing the day-to day quality operations at this location.”
 
American Contract Systems 11/6/18