Appearance as a Release Test? This is not the Way to get through an Inspection

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

The FDA has issued a Warning Letter to a manufacturer in the USA who has not adequately tested its drug products. And the manufacturer relied on others for supplier qualification.

The company in question put several batches of over-the-counter Mr. Lulu Sunscreen Drops SPF32 on the US market without testing the content of the active ingredients zinc oxide and titanium dioxide. The company does not conduct specified testing procedures prior to release, but only evaluates the medicines for scent, appearance and texture. The results of this assessment are not documented and there are no written procedures for testing and release.

Fittingly, incoming components used to manufacture the medicines were not adequately checked for identity. The associated supplier qualification was non-existent. It was simply assumed that suppliers were audited by others and therefore complied with regulations and ensured the quality of raw materials.

Thus, it is not surprising that a process validation programme is lacking and data to support basic process parameters such as mixing speed, time and temperature are not available.