Inspections and Audits

FDA Warns Arizona Manufacturer About Quality Issues

The FDA shot Signature Formulations a warning letter arising from an October inspection of the manufacturer’s Phoenix, AZ, facility that revealed cleaning and maintenance deficiencies and failure to test products and ingredients for conformance. Read More

Chinese API Maker Warned for Repeat Violations

The FDA issued a warning letter to an API manufacturing facility in Yicheng City, Hubei, based on a September 2017 inspection that found many repeat violations including a lack of validation studies and adequate API analysis. Read More

Chinese API Maker Warned for Repeat Violations

The FDA issued a warning letter to an API manufacturing facility in Yicheng City, Hubei, based on a September 2017 inspection that found many repeat violations including a lack of validation studies and adequate API analysis. Read More