Thursday, 29 September 2022 14.00 - 15.30 h
The U.S. Food and Drug Administration (FDA) issued a Warning Letter dated March 14, 2022, to an American manufacturer. During an inspection from September 23 to September 29, 2021, the FDA found significant violations of Current Good Manufacturing Practice (CGMP) concerning the firm's over-the-counter (OTC) drug product "Magic Heal".
According to the FDA, the firm failed to test "Magic Heal" for the identity and strength of each active ingredient prior to release for distribution. In addition, the company lacked approved specifications for this product.
The company failed to test active pharmaceutical ingredients (APIs) and other components prior to use in the manufacture of "Magic Heal". Furthermore, the company lacked approved specifications for these components. Where raw materials were received with a certificate of analysis from suppliers, it was missed to perform appropriate incoming analysis, in particular identity testing.
Another deficiency concerns calibration and qualification. The company did neither calibrate or verify the accuracy of the temperature-controlled function in the production, nor calibrated or qualified the scale used to weigh the drug components.
The FDA criticizes the company for not preparing adequate master and batch production records for "Magic Heal". Since also several changes to the manufacturing process without justification or change control were made, the FDA considers the batch records as inadequate.
According to the FDA, the company failed to ensure that all personnel are qualified for the CGMP operations they perform. At least, a respective documentation (training plan, training documentation, etc.) could not be presented.
According to the information given in the Warning Letter, the firm lacks a quality unit (QU) and approved written procedures defining QU responsibilities and controls. Written responsibilities and procedures for important GMP aspects (batch release, laboratory deviations, CAPAs, complaints, etc.) were not established.
Based on the deficiencies identified, the FDA considers the firm's quality system as inadequate. Moreover, in a previous inspection in June 2019, the FDA cited similar CGMP observations. For these reasons, the FDA strongly recommends that a consultant be engaged to assist the firm in meeting drug CGMP requirements.
To view the complete list of violations and the conclusion given by the FDA, please see the Warning Letter to Premier Trends LLC.