Unusual Warning Letter published by the FDA

Recommendation

2/3 May 2024

Process Validation - Live Online Training

In November 2014 we had reported about the FDA guideline "Guidance for Industry: Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection". This guideline determines how the FDA handles companies that delay, restrict or refuse an inspection or deny access to individual rooms respectively refuse the entire inspection. A current Warning Letter demonstrates the significance of this guideline.

The Warning Letter from 26 September, 2016 only has two pages listing 3 failures - but these are remarkable. The FDA criticizes that the head of the control laboratory had asked his employees to stand next to each other ("shoulder to shoulder") in such a manner that the FDA inspector had no complete access to the laboratory.

The second failure noted by the FDA was the company's refusal to provide copies of customer complaints (regarding glass, hair, cardboard, metal, discoloring and a black spider in their products).

The third issue critized by the FDA was how the head of quality assurance obstructed the FDA investigator in such a way that he could not take a picture of a device.

These failures lead to the products being regarded as adulterated according to the guidelines - leading to a ban on imports in this case.

More can be found in the complete Warning Letter to Nippon Fine Chemical.