FDAnews Drug Daily Bulletin
Pharmaceuticals / GMPs / Inspections and Audits

MHRA Withdraws GSK’s GMP Certificates for China Plant

Nov. 3, 2015

The UK’s Medicines and Healthcare products Regulatory Agency has withdrawn its GMP certificates from GlaxoSmithKline’s plant in Tianjin, China, that manufactures Zantac for the global market.

The MHRA reported a critical deficiency, citing failure to ensure that medical products were fit for their intended use, following a June 25 inspection of the plant. Specifically, since 2005, the company identified tablet discoloration in stability samples that did not meet shelf life specification, but no action was taken to assess the risk of products in the market or to ensure that a defective product was not supplied to customers.

A GSK spokeswoman says the company takes the action seriously and wants to ensure that its global supply network complies with all applicable regulatory expectations. The plant is undergoing repairs following a series of explosions at the Tianjin port area in August.