- The Food and Drug Administration reprimanded a South Korean drug manufacturer for failing to properly follow Good Manufacturing Practice (GMP) standards and mislabeling several over-the-counter skin products, issuing a warning letter to the company, Seindni Co. Ltd, in December.
- During the inspection, Seindni confirmed that the contract manufacturers it used to make its OTC drug products did not comply with GMP standards and failed to conduct release tests on the strength and identity of active ingredients.
- Notably, Seindni admitted that it regularly conducted finished product release decisions over the phone and didn't have procedures in place to document batch manufacturing and product quality.
At the crux of the FDA's concerns over Seindni's production practices is the company's relationship with a contract manufacturer.
Third-party drug contractors are frequently used by drugmakers to produce, test, package and label both active pharmaceutical ingredients and finished drug products. Yet, importantly, the FDA regards contractors as extensions of the source manufacturer, holding that original company responsible for the quality of all drugs produced.
Seindni's lax oversight of its contract manufacturer showed a lack of quality control over manufactured products, raising the FDA's ire.
After inspecting Seindni's facilities in May of this year, the regulator issued a Form 483 to the company, detailing potential areas of concern. After no response from Seindni, the FDA placed the company on its Import Alert list, barring the company's goods from entering the U.S.
Seindi has 15 working days to respond to the FDA's warning letter, which also recommends the firm retain a GMP consultant to help meet GMP standards.