Amneal injectables plant slapped by FDA for sanitary issues, improper working conditions

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.