Does successful completion of an FDA pre-approval inspection (PAI) influence the timing of a subsequent surveillance inspection? And should it?

[Related: For more on PAIs, view our recent webinar that includes insights from inspection trends presented by Redica Systems CEO Michael de la Torre.]

This topic was addressed by FDA representatives at the 2022 PDA/FDA Joint Regulatory Conference in mid-September in Washington, D.C. during the “Lunch with the Regulators” session.

Office of Regulatory Affairs (ORA) Division of Pharmaceutical Quality Operations Director Jeffrey Meng explained that PAIs and surveillance inspections are very different types of inspections, but because they are both agency inspections they may be perceived similarly.

In a PAI, he said, the objective is to cover readiness for commercial manufacturing. It focuses on the systems that govern the product that is the subject of the inspection.

Surveillance inspections, however, are different, as they cover the entire site. And since they are not equivalent, FDA would not waive a surveillance inspection because of a recent successful PAI. So, in general, having a PAI will not change the scheduling of a surveillance inspection.

CDER Office of Pharmaceutical Manufacturing Assessment Deputy Director Derek Smith noted that after a PAI is passed, the site enters the site selection model. This model is risk-based and considers numerous factors that impact when the next surveillance inspection will occur, taking into account a variety of quality signals such as Field Alert Reports (FARs) and Biological Product Deviation Reports (BPDRs).

Meng further explained that FDA tries to be efficient with inspection resources. He remarked that if a site comes up for a surveillance inspection at the same time as a PAI for the same site, the agency will work to combine those operations and assign investigators to conduct both at the same time, if possible.

Center for Veterinary Medicine (CVM) Pre-Approval Facilities Assessment Program Lead Laura Huffman also commented on the two inspection types. A PAI, she pointed out, is targeted, and uses information from the application. Whereas a surveillance inspection is more general, a PAI is “focused like a laser beam.” She noted that since the question comes up frequently perhaps the agency needs to do a better job communicating the purpose of each of those inspection types.

Intelligence on PAI 483s

Redica Systems intelligence shows that the top three common 483 observations from human drug GMP PAIs are deviations/investigations, inadequate quality units, and laboratory controls.

Figure 2 Redica Human Drug GMP Labels on PAI Inspections — **Redica Systems | Top 3 PAI Issues from 483s**

For more PAI and other inspection insights, contact us for a tour of the Redica Systems platform to see how our enforcement trend analytics can help you with inspection preparation.