Quality issues at ex-Sun Pharma plant land Frontida with US FDA warning

By Dan Stanton

- Last updated on GMT

Image: iStock/CountDuckula
Image: iStock/CountDuckula

Related tags Pharmaceutical drug Fda

The Pennsylvania plant released 27 lots of clonidine HCl tablets containing potentially contaminated active pharmaceutical ingredients (APIs), among several violations of cGMP the Agency said.

In June​, Frontida Biopharma bought two manufacturing facilities from Indian drugmaker Sun Pharma in Philadelphia, Pennsylvania, and Aurora, Illinois. But just two months on and the firm has received a warning letter from the US Food and Drug Administration (FDA) citing GMP violations at the Pennsylvania site.

The observed violations focused on failures in establishing an adequate quality control unit with the responsibility and authority to approve or reject all components of the drugmaking process at the plant.

The issues cited by the Agency came from an inspection in June and July 2015, and review responses sent to the FDA in August the same year, ten months before Frontida – a privately held contract manufacturing affiliate of Frontage Laboratories – took control of the site.

cGMP violations

These included the release of potentially contaminated product from the site:

“Your quality unit knowingly released 27 lots of various strengths of clonidine HCl tablets on or about March 5, 2015, despite evidence that active pharmaceutical ingredient (API) used in their manufacture (lot (b)(4)) was potentially contaminated,”​ the FDA said in the letter​.

“Your supplier recalled this lot of API based on (b)(4) inspectional findings that indicated inadequate controls to prevent cross contamination of the API. Your firm was notified of this recall as early as July 16, 2014.”

A contract testing laboratory was hired at the time to analyse retain samples of the clonidine API lot for cross contamination but the third-party used a test method not validated to detect low levels of cross contamination, which it explicitly said may not be used for batch release.

“Despite this, your firm released the 27 lots of clonidine HCl in March 2015 without testing your finished products using a method that was both validated and sufficiently sensitive to detect cross contamination,”​ the FDA said. “On July 9, 2015, during our inspection, your firm recalled all 27 lots.”

The FDA also said the firm had failed to adequately investigate the stability failure of a lot of felodipine 2.5-mg tablets for an unknown impurity, and said the facility’s quality unit failed to ensure that cGMP-related records were accurate, contained appropriate documentation, and were consistent with standard operating procedures (SOP).

Frontida must now provide a remediation plan to the FDA surrounding its quality control unit, and conduct a retrospective evaluation of its drug products within expiry to ensure they do not exceed specifications for any known or unknown impurities.

The firm did not respond to requests by this publication for further information at the time of going to press.

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