FDA Warns Alpha Laboratories To Fix Flaws at Contract Testing Facility

In a warning letter posted online July 12, the Food and Drug Administration told Alpha Laboratories Inc. that agency inspectors determined that the company’s testing facility had not complied with current good manufacturing practice (cGMP) requirements.

In the May 5 letter, FDA said that as a result of October 2010 inspections, products tested by the laboratory were considered “adulterated” under the Federal Food, Drug, and Cosmetic Act (FFDCA). The agency also told Alpha that until all the infractions are corrected and the company could confirm its compliance with cGMP regulations, FDA could withhold approval of any new applications or supplements ...