News

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Washington Homeopathic Products, Inc. due to specific violations of CGMP regulations. These violations include failure to establish an adequate quality control unit, failure to conduct at least one test to verify the identity of each component of a drug product, and failure to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods.

Once again, the lack of laboratory data integrity, beside other observations, caused the issuance of a US-American FDA Warning Letter and resulted in deficiencies mainly focused on the solvent recovery processes.

The Austrian competent authority has published a Statement of Non-Compliance with GMP to an Austrian manufacturer after a distance assessment. The Manufacturing Authorisation was now revoked.

The U.S. Food and Drug Administration (FDA) has recently published a Warning Letter to a Canadian over-the-counter (OTC) drug producer. During an inspection, the FDA found significant violations of current good manufacturing practice (CGMP), including data integrity issues related to HPLC analysis.