www.fdanews.com/articles/187319-fda-hits-texas-compounder-for-inadequate-documentation-gmp-issues
FDA Hits Texas Compounder for Inadequate Documentation, GMP Issues
June 21, 2018
The FDA warned a Texas compounding pharmacy for lacking prescriptions for some compounded drugs and for various GMP deficiencies.
The agency’s warning letter to Moore’s Pharmacy in Sinton cited observations from an August-September 2016 inspection in which investigators found the facility lacked valid prescriptions for individually-identified patients for a portion of the drug products it compounded.
The compounder also failed to properly investigate unexplained discrepancies or failures of batches of components, whether or not the batch had already been distributed.
