GMP News - Inspections/Audits

According to the U.S. FDA, the Chinese firm failed to establish an adequate quality system and lacks quality oversight on documentation.

Again the US-American FDA has issued a Warning Letter which primarily describes defects in the water system as well as deficiencies in the handling of CAPA & OOS and in the cleaning.

In August, the US FDA issued a Warning Letter due to cross-contamination with penicillin in areas for non-beta-lactam production.

Indian sterile manufacturer Emcure Pharmaceuticals has once more received a warning letter from the FDA with concerns to the root cause analysis of deviations in sterility testing.

The MRA with the USA is now in force as planned. But there is a lot to be considered in order to stop import testing.

Over and over again, FDA inspectors discover violations of long-established GMP requirements. Read more about which trends in the areas of quality control and production can be identified from the analysis of the Warning Letters issued in the last 21 months.

"Your firm's quality systems are inadequate". A sentence in a Warning Letter you would not like to read. Some companies now had to.