An Amneal Pharmaceuticals injectables manufacturing plant in India has been hit with an FDA citation after an agency inspection in late December.
In a Form 483 filing (PDF), the FDA flagged 15 observations, including numerous sanitary issues.
FDA inspectors visited the site in Ahmedabad, India, from Dec. 13-23. The team said employees working in one area were not wearing protective eyewear and that a "mold-like" substance was identified in another spot.
Additionally, the inspectors observed a production operator having to squeeze sideways and raise their arms in order to access a workspace.
“It appears that [the company] provides production personnel limited space to perform required aseptic set up activities,” the report said.
Another observation centered on a lack of cleaning and sanitizing.
Amneal is based in New Jersey but operates several production sites in India and one in Ireland.
Last fall, the company telegraphed plans to shutter a plant in Long Island, New York, and lay off 89 staffers.