Klinge Chemicals Limited – FDA Warning Letter, Jun 3, 2010

On December 21, 2010, the FDA issued a Warning Letter to Klinge Chemicals Limited following a June 1-3, 2010 inspection of their API manufacturing facility in Scotland. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP), rendering their APIs adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to ensure appropriate water quality:** The firm failed to establish and qualify procedures for controlling and monitoring their (b)(4) water system, used in the final purification step of (b)(4)-USP, an API for parenteral drugs. This deficiency was previously noted in a 2003 FDA inspection. 2. **Lack of a stability program:** Klinge Chemicals failed to establish a stability program to monitor manufactured APIs, with no testing of (b)(4) API in the last three years. 3. **Quality unit deficiencies:** The quality unit failed to ensure APIs complied with CGMP and specifications. Finished product assay and volumetric solution standardization procedures did not meet USP standards, and the firm lacked access to the USP.

The firm's June 11, 2010 response was deemed inadequate. The FDA also noted the firm's failure to register and list all APIs in commercial distribution in the U.S., as required by 21 C.