Warning to Macco Cites Flying Insects in Bag

Macco Organiques, a Canadian active pharmaceutical ingredient (API) manufacturer, was cited in a warning letter after inspectors found live flying insects in a large bag of material next to production equipment.

Macco’s Form 483 response indicated it would improve its practices and has procedures to control insects, housekeeping and raw materials. But the response lacked a specific corrective action plan for maintaining and cleaning the warehouse and production areas to prevent contamination.

Macco is neither registered with the FDA nor has it listed every API it commercially distributes in the U.S., the letter says. Although the agency investigator discussed this with the company, its Form 483 response did not address the issue.
Drug GMP Report