FDA sends warning letter to KVK-Tech manufacturing facility

The US Food and Drug Administration (FDA) has sent a warning letter to KVK-Tech’s drug manufacturing facility following an inspection in April 2019.

The document identified significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals. The FDA issued the warning letter to KVK-Tech in February 2020, advising that due to these cGMP breaches, the company’s products are adulterated according to the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Key violations identified by the FDA

FDA investigators reported specific violations including, but not limited to:
1. Inadequate validation of test methods: KVK-Tech failed to establish and document the accuracy, sensitivity, specificity and reproducibility of test methods.
2. Insufficient investigation of discrepancies: The company failed to thoroughly investigate any unexplained discrepancies, or the failure of batches or any of their components to meet specifications, including whether the batch had already been distributed.
3. Poor control over computer systems: There was a lack of appropriate controls over IT to ensure that only authorised personnel could make changes to master production and control records.

The firm failed to properly integrate co-eluting peaks during impurity testing of phentermine HCL capsules, which lead to undetected out-of-specification (OOS) results for at least one production batch, which remained on the market despite the company identifying the problem in 2016.
Additionally, KVK-Tech inadequately investigated foreign particles found in a batch of methylphenidate oral solution. Although the particles were filtered out, the company failed to thoroughly examine their origin, nature, and potential impact on drug quality.

The FDA also highlighted concerns about data integrity, noting that data files could be modified or overwritten without being captured on audit trails of stand-alone laboratory equipment.

What’s next for KVK-Tech?

The FDA has mandated that KVK-Tech promptly investigate and address these violations to prevent recurrence. Failure to do so may result in legal action without further notice. The company was required to respond within 15 working days of receiving the warning letter, detailing the steps taken to rectify the violations.

The warning letter to KVK-Tech underscores the FDA’s commitment to enforcing cGMP regulations and ensuring the safety and efficacy of pharmaceutical products.