U.S. sterile manufacturer racks up 13 observations in FDA visit

Courtesy of Pyramid Laboratories

The FDA was not impressed with the aseptic filling operations at a California facility that it inspected earlier this year, laying out more than a dozen observations.

Inspectors spent 10 days at the contract manufacturer Pyramid Laboratories in January in Costa Mesa, CA. The agency issued a Form 483 with 13 observations, which it posted publicly on its website last week.

Among problems noted by inspectors, was Pyramid's failure to investigate half a dozen "action level environmental excursions" out of 19 environmental excursions that came up last year. That included a nonviable particle excursion which occurred in November in the company's Class 10,000 component preparation room.

The inspectors also faulted the facility for not properly training employees on visual inspection of injectable drugs and sterile biologics. It said that new inspectors were held to a lower standard than experienced inspectors.

Inspectors also noted that Pyramid failed to require a supplier to provide test results on endotoxin specifications for sodium acetate trihydrate crystals. Further, inspectors criticized Pyramid for failing to conduct some particulate monitoring during a shift.

The company did not respond to a request for a comment, but according to its website, its manufacturing facility, quality control labs and corporate offices are housed in three buildings at its 70,000-square-foot operation.

There has been an upswing in sterile manufacturing of biologic products as they have become larger percentage of the portfolios of many drugmakers in recent years. But the FDA has been watching them closely because sterile injectables are more difficult to manufacture. Fresenius Kabi recently announced that the FDA will again allow it to seek drug approvals for its APP Pharmaceuticals sterile manufacturing plant in New York that was cited in 2012 after inspectors found insects in some of the drug vials, along with other problems. Hospira ($HSP) has had the opening of a large new sterile manufacturing facility in India delayed because the FDA after two preopening inspections still has issues with it. The agency issued 14 observations during its last inspection.

- here's the Form 483 (PDF)