BRIEF-Dr Reddy's receives FDA warning over complaints

The US regulator has  sent a Form 483 warning to the India-based active pharmaceutical ingredient (API) producer Dr Reddy’s Bollaram, regarding a number of deficiencies including a failure to respond to complaints about out-of-specification (OOS) results.

The US FDA says three complaints were received, related to microbiological failures.

In addition, the regulator said customers have complained about being shipped the wrong type of API, raising questions about the firm’s barcode system.