WHO Holds Off on Recalls Following Non-Compliance at Indian Site
Although the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a statement of non-compliance for significant deficiencies at Micro Labs’ Hosur, India-based site, the World Health Organization (WHO) said this week that a recall of prequalified medicinal products “is not considered to be necessary.”MHRA carried out the good manufacturing practice (GMP) inspection last November and “identified failures in the cross-contamination controls applied by the manufacturer resulting in a risk of cross contamination above Permitted Daily Exposure (PDE) from some products.”
Member states were told by MHRA to contact the site to determine the level of risk associated with specific products. “MHRA would recommend consideration of recall of any products where manufacture followed low PDE products in equipment used for granulation, blending, compression,” said the statement of non-compliance issued on 24 January.
Since the statement, WHO says that Micro Labs has suspended the manufacturing and supply to the EU market of non-critical finished pharmaceuticals manufactured at the site, while addressing the issue.
“Until WHO confirms that all matters have been resolved, it is recommended that procurers and distributors contact the company to determine the level of risk associated with specific products and consider alternative suppliers of these medicines, where appropriate. Procurers and distributors of finished pharmaceutical product (FPP) manufactured by Micro Labs Hosur (Unit 03) may contact WHO for further information,” WHO said.
The UN agency also said the site manufactures different versions of pyrazinamide, isoniazid, levofloxacin, protionamide, ethionamide and moxifloxacin.
WHO response to UK MHRA Statement of Non-Compliance with GMP on Micro Labs Hosur (Unit 03) manufacturing facility