Inspections and Audits

Alchymars Warned for Falsified Data, Maintenance Issues

The FDA hit Indian API manufacturer Alchymars ICM SM with a warning letter after an investigation found the firm falsified laboratory data, failed to thoroughly investigate complaints and improperly maintained equipment and facilities at its Chennai, Tamil Nadu facility. Read More

Bray Group Cited for Multiple Violations

The FDA issued U.K. drug manufacturer Bray Group a Form 483 after finding numerous violations during an inspection of the firm’s Faringdon, Oxfordshire facility, including problems with validations, sample testing, cleaning and maintenance. Read More