Statistical Analysis of FDA's Inspection Findings
Recommendation
29/30 October 2024
Organisation of a GMP-compliant Site Change
The deficiencies observed by FDA inspectors are written down in the so-called Form 483. Unlike Warning Letters, those aren't available online and have to be requested individually by post. Yet, FDA's evaluation of findings listed according to their frequency is pretty unknown. This is a very easy way to find out frequently observed deficiencies. In the fields "Drugs" for example, the lack of or the non-compliance with written instructions is ranked first. The second position goes to failures in the investigation of deviations.
The observation summary counts more than 5.000 483 Forms - including in addition to drugs also further fields like foods which have been analysed separately.
Another interesting summary is the webpage with FAQs relating to the 483 Form.
The following graph shows an analysis of the 483 identified during fiscal year 2013.
Related GMP News
23.10.2024Warning Letter to Indian sterile Manufacturer due to Cross-Contamination and Particles
16.10.2024Do Parenterals have to be 100% free of Particles?
02.10.2024Does Purified Water have to be tested for Endotoxins?
18.09.2024FDA issues Warning Letter to Cell Gene Therapy manufacturer
11.09.2024Humidity in pharmaceutical Cleanroom Walls after a Leakage
28.08.2024FDA Warning Letter to pharmaceutical Manufacturer in Puerto Rico