U.S. sterile manufacturer racks up 13 observations in FDA visit Pyramid Laboratories faulted for failing to root out environmental issues March 17, 2015 | By Eric Palmer

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. more