The use of "flaking" and non-sterile gloves in aseptic processing, as well as cGMP violations, has led to the the US FDA issuing a warning letter to Agila for its Bangalore, India plant.
The letter , which was issued following an inspection in June, cited seven substantial violations of current good manufacturing practices (CGMP), the most significant being the use of non-integral and non-sterile gloves for aseptic processing. The letter also follows Agila's failure to respond adequately to issues addressed in a 483 from the FDA.
“Visible holes and flaking were observed” both in gloves used during the processing of a vial batch and in the firm’s warehouse. Furthermore, “the cardboard boxes used to ship and store these gloves were also found to be damaged,” the letter said, and “crushed insects were found on one of the glove’s outer package inside the shipping box.”
Earlier this month, Mylan was cleared by Indian regulators to complete the purchase of Agila for $1.6bn (€1.2bn). However, Mylan said last week that the warning letter will not have an impact on the acquisition of the Indian aseptic facilities.
483 and Issues Addressed?
In July following Strides Arcolab - Agila’s then owner - received a Form 483 but in an earnings call at the time Stride’s Managing Director Arun Kumar told investors he was “confident that the 483 issues will be addressed” and had responded to the FDA in the stipulated time.
However, the FDA found the response lacked “sufficient corrective actions” and on top of the glove sterility problem cited a number of other violations:
- The inspectors found Agila’s media fill studies were inadequate, with a significant number of media fill vials rejected without justification.
- A failure to establish adequate system for monitoring environmental conditions in aseptic processing, with inadequate contamination risk assessment taking place.
- Further issues of cleanliness and hygiene were noted, including water damage and the presence of mould growth on finished product shipping containers in the cold storage room. The letter did, however, acknowledge some corrective actions had been taken by the firm but did ask Agila to “address the presence of mold spores in the cold room.”