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Regulatory News | 08 March 2017 | By Michael Mezher
The US Food and Drug Administration (FDA) has warned Wockhardt subsidiary Morton Grove Pharmaceuticals over quality control and data integrity issues.
In a warning letter dated 17 February, FDA details six violations uncovered during a month-long inspection of the Morton Grove, Illinois facility in January and February 2016. In 2014, FDA issued the site a Form 483 detailing 12 observations covering product testing, recordkeeping and data integrity issues.
In a filing with the Bombay Stock Exchange last week, Wockhardt acknowledged the warning letter, noting that it will still be able to market products made at the facility, and said the company had hired consultants to help it address the issues cited in the warning letter.
The warning letter is the latest in a series of regulatory setbacks for Wockhardt. Since 2013, FDA has sent Wockhardt and its subsidiaries five warning letters and one untitled letter addressing deficiencies at seven of the company's sites.
According to FDA, all seven sites are out of compliance with current good manufacturing practice (cGMP), and three have been placed on import alert.
In the most recent warning letter, FDA says Morton Grove failed to adequately investigate out of specification (OOS) test results, and continued to ship batches of the product that could have potentially been affected.
Specifically, FDA says the company concluded that impurities found in two batches of triamcinolone acetonide lotion did not pose a risk to patients, without conducting a scientific evaluation, and continued to distribute other batches of the product while its investigation remained open.
According to FDA, Morton Grove management told the agency the investigation into those batches "fell through the cracks."
FDA also cites the company over failed tests for the its fluticasone propionate nasal spray, saying the company invalidated failed results without scientific justification and only considered the re-tests in batch release decisions.
However, FDA says the company was manufacturing fluticasone propionate nasal spray using an "unvalidated and experimental manufacturing process." And, despite multiple batches of the product failing to meet specifications, the company did not look to its manufacturing process as the potential cause.
"When significant variability is observed in one or more stages of pharmaceutical production, it is essential that executive management support and implement effective actions to address the source(s) of the variation and provide for a continued state of control. Your firm does not have an adequate ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality," FDA writes.
FDA also notes that Morton Grove failed to address data integrity issued it committed to fixing after receiving the 2014 Form 483.
Specifically, FDA says the company's IT staff share usernames and passwords and are able to "delete or change directories and files without identifying individuals making changes."
In addition to the other deviations cited, FDA says the Morton Grove facility failed to submit field alert reports (FARs) to the agency. These reports, FDA says, are meant to "quickly identify drug products that post potential safety threats," and are required to be submitted to FDA district offices within three days.
In this case, FDA says the company failed to submit a FAR when it identified OOS results for batches of its fluticasone propionate nasal spray in June and August 2015.
"You did not submit a FAR until the second day of FDA's inspection, January 5, 2016, more than six months after you discovered the initial OOS," FDA writes.
Tags: Warning Letter, Data Integrity