Basics of 4 types of FDA Inspections

If you're a manufacturer or a processor of FDA-regulated products, you'll expect a visit from FDA. the aim of this visit is to verify compliance with all relevant regulations — most ordinarily stated as an “FDA inspection.”  But not all inspections are created equal.

FDA performs four kinds of inspections at many various kinds of facilities, and your company’s response should be tailored to the precise sort of event. Facilities that represent FDA’s watchful eye include:

ü  Drug manufacturers

ü  Device manufacturers

ü  Blood banks

ü  Food processing facilities

ü  Dairy farms

ü  Animal feed processors

ü  Compounding pharmacies relevant to your FDA inspects

ü  Facilities that conduct studies in people

ü  Laboratories that conduct studies in animals (support FDA approval of medical products)

FDA’s inspection authority also extends to foreign manufacturing and processing sites for FDA-regulated products sold within the US. Fall within these bounds, and you'll expect an FDA inspection at your facility.

The four differing kinds of inspections conducted by FDA are pre-approval inspection, routine inspection, compliance follow-up inspection, and “for cause” inspection.  Each is meant to assist protect the general public from unsafe products, but the main target and expectations of every sort of inspection are different.

Ø  Pre-Approval Inspections are conducted after an organization submits an application to FDA to market products for NDA or ANDA. These inspections target verifying data included within the application, and confirming that the firm is capable of producing said product. At the end of inspection inspectors will recommend for or against FDA approval.

Ø  Routine Inspections are expected at every 2 years for Class II and Class III device manufacturers.  They follow a prescribed method referred to as Quality System Inspection Technique (QSIT). If a heavy public health risk is identified during a routine inspection, the inspection type may then switch to a “for cause” inspection.

Ø  Compliance Follow-Up Inspections assures actions taken by a facility in response to a previous audit that resulted in significant 483 observations or a Warning Letter. This inspection is conducted to verify the adequate correction of previous discrepancies, to document continuing violations, or to support future regulatory action.

Ø  “For Cause” Inspections investigate a particular problem that has been reported to FDA. The source of the report will be the manufacturer (e.g., resultant of a recall, MDR), consumer/user complaints, or perhaps a dissatisfied employee.  A “for cause” inspection will target the definite issue, but can expand to hide unrelated elements of the firm’s operations. This inspection usually is initiated at the request of CDRH, ORA, or regional directive. These inspections typically are more in-depth than routine audits, and that they might not follow a QSIT approach.

Source: https://www.meddeviceonline.com/doc/understanding-the-types-of-fda-inspection-0001