The facility in Sriperumbudur, India - in Chennai's Irungattukottai neighbourhood - makes liquid and powder antibiotics and solid dose drugs. UK Medicines and Healthcare products Regulatory Agency (MHRA) inspectors who visited the site in July found sterility problems in production areas.
These include the discovery of "aseptic processes that had not been optimised to reduce the risk of microbial contamination" and that "the environmental monitoring program was not based on a scientific justification."
The MHRA inspectors also said "sterilisation activities including poorly designed autoclave load patterns" were observed and that staff employed "manual interventions that were not appropriately detailed."
The London, UK-based agency withdrew the site’s good manufacturing practices (GMP) certificate (UK GMP 36736 Insp GMP 36736/1707035-0003).
It also recommended that certain products made at the plant should not be sold in the European Union (EU) until the problems are addressed.
“No future batches of non-critical sterile product to be supplied to the EU while this statement of non-compliance remains in force. This prohibition does not apply for Solid-dosage products such as tablets and capsules.”
In an emailed statement Pfizer told us it "has formally responded to the inspection findings issued following the recent inspection of the legacy Hospira Irungattukottai, India site.
The firm added that: "The site is implementing actions to address the findings."
Drugs made at the Sriperumbudur plant include Primaxin (Imipenem/cilastatin), Tazocin (piperacillin/tazobactam) and ceftazidime.
Hospira has operated the facility since 2010 when it bought Orchid Chemicals and Pharmaceuticals’s generic injectables business for $400m (€354m).
The facility has also been the subject of US Food and Drug Administration (FDA) criticism. The US agency issued Hospira with a warning letter after a visit to the site in 2012.
An inspection conducted in December 2013 earned Hospira a Form 483 detailing 23 observations.