The FDA served Korean drug manufacturer Nowcos a warning letter after an inspection revealed multiple validation deficiencies and inadequate stability studies.

An August inspection of the firm’s Seoul facility brought several validation issues to light. For example, the firm did not validate manufacturing processes for its over-the-counter drug products and did not perform process qualification studies. It also lacked a program to monitor process control and ensure manufacturing operations were stable.

The firm did not validate its test methods or establish procedures for sampling raw materials and finished products, and did not perform growth promotion testing on items used for microbial testing of finished OTC drug products.

In addition, the facility did not perform cleaning validation studies, making it unable to prove its cleaning procedures for non-dedicated production equipment sufficiently prevented cross-contamination.

The firm’s stability studies also did not sufficiently ensure that its OTC drug products remained within specification throughout their labelled expiry period.