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FDA form 483 issued to Mylan Pharmaceuticals' manufacturing facility in Morgantown, WV for lapses in quality control

Mylan Pharmaceuticals’ manufacturing facility in Morgantown, WV, received an FDA Form 483 due to lapses in quality control and GMP violations. The FDA inspection of the site took place earlier this year and it was a 12 day inspection.

In the 32 page form 483, there were almost 13 situations of noncompliance to Good Manufacturing Practices which included lack of appropriate oversight and documentation on written procedures, changes to an inadequately validated cleaning process and established time limits on drug products. There were seven observations related to Quality Control Unit which included:

1) The quality unit was unable to provide documentation for each manufacturing change made within the lab information management system that had not been assigned a change control since November 2016 “as these changes are not tracked, reviewed or approved” according to FDA.
2) The quality unit had opened a total of 462 investigations since November 2016 into a hold time set for each drug manufacturing phase that was being "frequently exceeded" by the production department without implementing any corrective and preventive actions.
3) The most extensive observation cited the quality unit’s failure to “adequately validate the cleaning processes of all manufacturing equipment and utensils shared between the firm’s 230 oral dosage drug products (potent and non-potent) to ensure no cross-contamination of active ingredients and detergent occur between products.
4) Six examples showed site's inadequate cleaning process which included lack of "sound scientific rationale" for the quality unit's decision to invalidate certain swab results based on re-swab results in a different location of the selected manufacturing equipment
5) Three examples showing poor cleanliness of equipment included, an “unknown crystal-like yellow residue” seen on equipment that had been used to manufacture Verpamil HCI SR tablets, as well as residue observed on an encapsulator used in the manufacturing of Diltiazem HCI ER capsules.
6) Laboratory analyses were being repeated until obtaining passing results in cleaning verification tests for products or detergent residues which was again a major cleanliness issue as noted in Form 483 at the time of site’s inspection.
7) 10 instances on back dating was observed wherein investigators observed equipment components being re-cleaned and re-swabbed until the analyses showed the desired results dating back to Aug 2016.
8) Retrospective review of liquid chromatography systems by quality unit failed to include folders on cleaning and method validations.
9) Other issues as noted in form 483 included failure to conduct visual examinations of reserve samples from sample lots or batches, follow written production and process control procedures, and follow-up on written records of drug complaint investigations.

According to Mylan they have submitted a comprehensive response to the observations cited in Form 483 to FDA including a massive improvement plan. The site is continuing to manufacture and ship the product from the site ensuring the quality, safety and efficacy of drug products.