Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The Learning Portal will be under maintenance Monday, 6 December between 6 AM and 5 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.
Posted 11 October 2018 | By Ana Mulero
Following the 13 nonconformities that were revealed during a US Food and Drug Administration (FDA) inspection of a Mylan Pharmaceuticals manufacturing site, Focus obtained a copy of the company’s response to the agency via a Freedom of Information Act (FOIA) request.
The response to the 31-page Form 483, which was issued after the FDA visit to the plant in Morgantown, WV earlier this year, outlines a total of 77 commitments to address the inspectional observations. The issues were mostly related to failures of the quality control unit.
Some of Mylan’s reported commitments have already been completed, dating back to 2016 and 2017, while others were still in-process at the time of the submission to FDA. Most of the actions that were reportedly underway were redacted due to FOIA exemptions from public disclosure.
At least some of the disclosed commitments, however, provide an inside look into how the actions seek to resolve specific issues noted by the FDA investigators. “This self-assessment included a cross-functional team, outside of daily operations, that further assess quality systems,” wrote Kimberly Kupec, head of OSD quality at the Mylan facility in Morgantown.
The 483, for example, pointed to multiple instances of a lack of documentation, including for the transfer of tablet presses and an observed exposure of a product to a room.
“It was determined that the product was left uncovered when the operator left for the shift change around the time the machine was shutdown. No operator was assigned to continue processing the product during the next shift,” the 483 said. In response to these observations, Mylan reportedly committed to conducting an effectiveness check “to verify that documentation is not being discarded.”
“If any of the effectiveness checks identify noncompliance, additional actions will be documented, implemented and additional effectiveness checks conducted,” Mylan added.
Only three of the commitments were set to be completed earlier this year—two of which are aimed at evaluating the effectiveness of updates to procedures deemed inefficient by FDA. The status on these two was not specified. The remaining action was reported to be “in-process.”
There are a few other in-process commitments that were not completed by their 2017 due dates as well. These were mostly related to three initiated corrective and preventive actions.
According to the response letter, the company intends to update the status of the remaining commitments in its charted course to quality manufacturing improvement on a bi-monthly basis.
Tags: 483, FOIA, Quality
Regulatory Focus newsletters
All the biggest regulatory news and happenings.