- The Food and Drug Administration earlier this month warned Indian manufacturer Malladi Drugs & Pharmaceuticals Ltd. of GMP violations at its Chennai plant, raising red flags over the company's production processes after agency inspectors found vermin near drug equipment.
- A review of the facility in September revealed Malladi produced some active pharmaceutical ingredients in parts of its facility that are open to the outdoors. In addition, records showed Malladi struggled to reproducibly manufacture API to specification, with 24 batches of product yielding out-of-specification results over a two-year period.
- The company responded to the FDA's concerns later that month but the FDA was unconvinced, placing Malladi on import alert in December and issuing the company a warning letter on March 9.
Malladi won itself no favors with the FDA by producing API in open-air areas of its facility. In its warning letter, the agency noted matter-of-factly that the presence of birds and insects near manufacturing equipment posed a risk of contamination.
Although that GMP violation is the most alarming on its face, Malladi also fell short of FDA standards in other areas that many of its India-based peers also struggle with.
Malladi's API production equipment was not appropriately designed and couldn't be reproducibly cleaned, the FDA said in its letter.
Furthermore, Malladi didn't appropriately validate its manufacturing processes, leaving sources of potential variability unaddressed. Over two years, two dozen batches tested out of specification for an unspecific impurity. While Malladi rejected some of those batches, the FDA lacked confidence Malladi's processes couldn't prevent such aberrant results in the future.
As with many other cases of GMP violations, the FDA recommended Malladi retain a GMP consultant to help it get its plant in order.
In addition the Chennai facility in question, Malladi operates four other plants in India and a fifth in New Jersey. Most of its work centers on API production for cough and cold medicines, as well as for neurological drugs.