GMP News - Inspections/Audits

The unpopular deficiency letters of the FDA contain numerous standard formulations and follow a fixed scheme in their structure. Read more here about the structure of the Warning Letters and why their reading can be very useful in preparing for an FDA inspection. 

A manufacturer of homeopathic drugs and hormone preparations in the USA has received a Warning Letter from the FDA due to several GMP violations. Among other things, highly active drugs were produced on the same equipment as the other products.

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a firm that manufactures and distributes OTC products. The Warning Letter summarizes significant violations of current Good Manufacturing Practice (CGMP). The company failed, amongst others, to have the proper controls in place to prevent the unauthorized manipulation of laboratory raw electronic data. Furthermore, the laboratory management could not provide an adequate explanation for several unofficial HPLC injections.

Inspectorates are restarting domestic on-site inspections. Announcements were made by FDA and MHRA.

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.