Newly posted warning cites repeat violation

Warning letters posted by the FDA this week cite two companies for manufacturing violations. One involves procedure documentation, the other, a repeat occurrence of a facilities issue.

At IriSys in San Diego, an inspection in the spring turned up inadequate and process control documentation. In producing Donnatal Elixir, a treatment for irritable bowel syndrome, operators made such modifications as adjusting mixing times and changing the order in which raw materials are added. But they did so without adequate written procedures, the letter says. So the process can't be confirmed as "capable of routine commercial manufacturing."

IriSys responded that its strategy during process validation was concurrent release of batches. "We expect rare use of concurrent release of batches," the FDA says. "But if you choose to release batches concurrently, you should make conclusions about the manufacturing process only after the protocol is completed and you have fully evaluated your data."

Separately, during a late 2009 inspection of TYA Pharmaceuticals in Tallahassee, FL, inspectors found a lack of separation of certain processing operations involving penicillin. The repackaging of both penicillin and non-penicillin products took place inside a single hooded cabinet within a single laminar air-flow room.

TYA responded that it had discontinued the repackaging of penicillin products, and that the laminar air-flow room would be used to repackage only cephalosporin drug products. But the FDA rejected the proposal.

"We find your response to be inadequate because your firm has previously made similar assurances, but resumed repackaging penicillin and cephalosporin drug products in December 2008 without having full segregation in place to prevent cross contamination," the letter says. "This is a repeat observation from the February 2007 inspection."

- here's the IriSys warning letter
- see the TYA warning