Institute of Good Manufacturing Practices India®

"Magic Heal" Manufacturer Receives FDA Warning Letter

The U.S. FDA (Food and Drug Administration) issued a Warning Letter dated March 14, 2022, to an American manufacturer- Premier Trends LLC. During a check from September 23 to September 29, 2021, the FDA discovered substantial breaches of Current Good Manufacturing Practice (CGMP) regarding the firm's over-the-counter (OTC) drug product "Magic Heal."

As per the FDA, the firm failed to test "Magic Heal" for the identity and strength of each active ingredient before releasing for distribution. Further, the company lacked authorized specifications for this product.

The group failed to test active pharmaceutical ingredients (APIs) and other components before use in the manufacture of "Magic Heal." Also, the company lacked approved specifications for these components. Another deficiency concerns calibration and qualification, not preparing adequate master and batch production records for "Magic Heal." 

The company failed to ensure that all personnel was qualified for their CGMP operations. 

The firm lacks a quality unit (QU) and approved written procedures defining QU responsibilities and controls.