Summary of Warning Letters Issued by FDA in 2018 Q1

Also read: Analysis of Warning Letters Issued by FDA in 2018 Q1

Main problems inspected:

Problems of API enterprises were relatively superficial, for example:

Failureto adequately investigate out-of-specification results and implementappropriate corrective actions.

（Warning Letter 320-18-41，Keshava Organics Pvt. Ltd.）

Failure to use appropriate precautions to minimize the risk of API contamination where open equipment is used

Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes.

（Warning Letter 320-18-40 Malladi Drugs & Pharmaceuticals Limited）

Failureto have laboratory control records that include complete data derived from alllaboratory tests conducted to ensure your API complies with establishedspecifications and standards.

Failureto properly maintain equipment and to keep complete records of major equipmentmaintenance.

（Warning Letter 320-18-35 Alchymars ICM SM Private Limited）

Process validation and laboratory basic management, and production and equipment management problems are very common and the most basic GMP management content in the production and daily quality management of pharmaceutical product manufacturers. The large gap and defects in this regard are worth pondering, showing weak GMP foundation and producers’ weak GMP awareness of some API manufacturers.

Regarding problems in preparation enterprises, there were more in QC laboratory part, for example:

Your firm failed to establish and document the accuracy, sensitivity, specificity, andreproducibility of its test methods (21 CFR 211.165(e)).

Your firm failed to ensure that laboratory records included complete data derived fromal tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).

Your firm failed to conduct at least one test to verify the identity of each component of drug product. Your firm also failed to establish the reliability of component supplier analyses on which you rely in lieu of certain tests through appropriate validation of supplier’s test results at appropriate intervals (21CFR 211.84(d)(1) and (2).

Seen from defects listed in the warning letters, most were common problems in daily management and were very easy to avoid, and many superficial problems frequently occurred in the warning letters, precisely revealing that the essence of GMP management is basic management and detail management. Quality management cannot be established overnight, and weak quality awareness is the fundamental cause that leads to the warnings.

We can see from the above analysis of warning letters issued by FDA in 2018 Q1 that it’s necessary to start from the basis and promote quality system construction in a down-to-earth manner for a drug to maintain its good credit on the normalized market. The campaign-style management may result in certain progress, however, continuous compliance requires the system to be constantly improved and enhanced in the long run.

Also read: Analysis of Warning Letters Issued by FDA in 2018 Q1

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