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Regulatory Focus™ > News Articles > 2019 > 6 > FDA Warns Taiwan Drugmaker Over GMP Violations

FDA Warns Taiwan Drugmaker Over GMP Violations

Posted 11 June 2019 | By Michael Mezher 

FDA Warns Taiwan Drugmaker Over GMP Violations

The US Food and Drug Administration (FDA) last month warned Taipei, Taiwan-based drugmaker Vida International over good manufacturing practice (GMP) violations following an inspection of the company’s Taoyuan City facility last December.
As a result of the observations made during the inspection, FDA placed Vida on import alert in March.
In the warning letter, FDA cites Vida for failing to conduct necessary batch testing for one of its products before release.
“You released an over-the-counter (OTC) drug product [redacted] to the US supply chain without testing the identity, strength, purity, and other quality of the active ingredient. In addition, you did not adequately test for critical microbial attributes (e.g., absence of objectionable microorganisms, total count) before release,” FDA writes.
FDA also says the firm failed to test incoming raw materials, including active ingredients, to determine their identity and whether they conform to written specifications before use.
According to FDA, Vida also prepared an inaccurate batch record for a lot of one of its drugs that did “not represent the formula and ingredients that the product purports on its label.”
FDA says the batch record did not list all the active ingredients specified on the drug’s label and did not include “the actual amounts of each active and inactive ingredient used during manufacturing, a calculation of theoretical or actual yields, documentation of the equipment used, and [other] critical manufacturing parameters.”
Additionally, FDA says the company failed to establish an adequate quality control unit, noting that the firm lacked adequate written procedures for functions, such as the release of batches and overseeing its drug stability program.
While Vida provided a response to FDA in December, the agency says the response is inadequate and requests that the company provide a plan for testing samples of all batches of drugs distributed to the US and conduct a risk assessment for all products distributed to the US within expiry to estimate the impact of its testing lapses.
FDA also asks the company to clarify whether it intends to resume manufacturing drugs at the facility for the US market, and if so to provide additional information on test methods and specifications and batch release specifications. Furthermore, FDA says the company will need to put in place corrective and preventative action (CAPA) plans to address deficiencies related to its stability program and quality control unit.

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