News

In a Warning Letter to a manufacturer of non-sterile drugs, the FDA criticized, among other deficiencies, a lack of testing of the manufactured batches for microbiological quality in accordance with USP chapters <61> and <62>, which deal with the "Enumeration" test and the test for "Specified Microorganisms".

The GMP/GDP Inspectors Working Group decided at the end of 2023 to extend the validity of GDP and GMP certificates that expired at the end of the year until 2024 or until the next on-site inspection, whichever occurs first. It has now been clarified that from 2025, this extension no longer applies.

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to an American contract testing laboratory, emphasizing that it considers contractors as extensions of the manufacturer’s own facility. The authority identified critical deficiencies, including the failure to validate microbiological testing methods in accordance with USP standards and inadequate investigation of temperature and humidity deviations in laboratory equipment.

In January 2025, the U.S. FDA issued a Warning Letter on its webpage due to the lack of evaluation of impurities - also during the stability studies.