US FDA issues warning letter to GlaxoSmithKline

US FDA has issued a warning letter to GlaxoSmithKline for alleged manufacturing deficiencies at the company’s manufacturing subsidiary in Cork, Ireland. The subsidiary, SmithKline Beecham (Cork) Ltd., is a manufacturer of active pharmaceutical ingredients (API) for GlaxoSmithKline (GSK).

FDA inspected the manufacturing facility in October 2013 and identified the deviations from current good manufacturing practice (cGMP) for manufacturer of active pharmaceutical ingredient. FDA observed that the company failed to fully investigate critical deviations within the manufacturing processes. The company found out that batches used in manufacturing process were contaminated with material from your pharmaceutical waste tank, which contained APIs, intermediates, and solvents.

The company also failed to investigate and document the out of specification results and to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes. The company’s validation protocol states that a minimum of three consecutive pre-nominated process performance qualification (PPQ) batches were to be produced to demonstrate initial process validation. However, the company was unable to produce three consecutive successful batches during the production of multiple batches and therefore re-nominated the PPQ batches on two different occasions.

After this warning letter GlaxoSmithKline has recalled some batches of its antidepressants Paxil and Seroxat because the active ingredient used to make them might have been contaminated with a solvent from a pharmaceutical waste tank. The company is voluntarily withdrawing batches of the drug involved at wholesale level. The company has conducted a risk assessment of the active ingredient used in manufacturing of these drugs and found it safe for use in the manufacturing of the anti-depressants.