FDA’s Focus On Lab Practices Abroad Continues in Four Recent API Warning Letters

Laboratory practices – a recurrent area of concern in FDA inspections abroad – again took center stage in a series of warning letters issued by the Center for Drug Evaluation and Research (CDER) compliance office to four foreign active pharmaceutical ingredient (API) manufacturers in December.

The API manufacturers receiving the warning letters were: ● Klinge Chemicals (Glasgow, Scotland) ● Yuki Gosei Kogyo (Fukushima, Japan) ● Synbiotics (Ahmadabad, India), and ● Macco Organiques (Valleyfield, Quebec, Canada).  The inspections referenced in the letters were conducted in June, July, August and April, respectively, and lasted between three and five days.

Laboratory deficiencies were highlighted as a concern in all four letters, reflecting their prominence in the FDA data on 483s issued outside the US (IPQ “In the News” October 24, 2010).

[More on the four API warning letters and their common concerns are provided for subscribers here. Non-subscribers can purchase the full story for $95 by contacting Jonathan Trethowan (Jonathan@ipq.org).  For subscription information, click here.]