The UK regulator criticised Marksans's facility in Goa, India in a filing on EudraGMP last week, explaining it had observed good manufacturing practices (GMP) violations during an inspection in November.
According to the Medicines and Healthcare Products Regulatory Agency (MHRA) its staff found “evidence of destruction of multiple parts of records of prime data” at the facility.
The MHRA team also said Marksans could not prove that corrective actions taken after an inspection last spring – when the MHRA criticised the plant's pharmaceutical quality systems – had been effective.
“There was a lack of evidence to demonstrate the effectiveness of resultant CAPAs [corrective and preventative actions] taken and a lack of interim assurances to ensure that the on-going operations remain in compliance with GMP, including failures to carry out effective investigations.”
The MHRA withdrew a GMP certificate - UK GMP 19826 Insp GMP 19826/39398-0003 – previously issued to Marksans.
It also said: “No further MA should be approved naming the site as manufacturer. Current pending MA applications should be held or refusal to grant stated whilst this statement of non-compliance remains in force.”
In addition, the agency banned Marksans from supplying further batches of products not considered critical to public health until the observations are addressed.
The MHRA also suggested: “National competent authorities should evaluate the criticality of products supplied from this site and enact measures to ensure continued supply.
“Marketing authorisation holders are requested to contact the relevant National Competent Authority to verify whether their products are considered medically critical, and therefore outside the scope of this non-compliance statement.”
Marksans’ makes 40 plus drugs at the facility for customers including Israeli firm Teva Pharmaceutical Industries and UK supermarket chains Tesco and Waitrose. Products include generic versions of Pfizer’s Viagra (sildenafil) and Zocor (simvastatin).
The firm acknowledged the notice of non-compliance in a statement issued last week.