21 CFR § 1.503 - Who must develop my FSVP and perform FSVP activities?

---
identifier: "/us/cfr/t21/s1.503"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1.503 - Who must develop my FSVP and perform FSVP activities?"
title_number: 21
title_name: "Food and Drugs"
section_number: "1.503"
section_name: "Who must develop my FSVP and perform FSVP activities?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "1"
part_name: "GENERAL ENFORCEMENT REGULATIONS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271."
regulatory_source: "42 FR 15553, Mar. 22, 1977, unless otherwise noted."
cfr_part: "1"
---


# 1.503 Who must develop my FSVP and perform FSVP activities?

(a) *Qualified individual.* A qualified individual must develop your FSVP and perform each of the activities required under this subpart. A qualified individual must have the education, training, or experience (or a combination thereof) necessary to perform their assigned activities and must be able to read and understand the language of any records that must be reviewed in performing an activity.

(b) *Qualified auditor.* A qualified auditor must conduct any audit conducted in accordance with § 1.506(e)(1)(i) or § 1.511(c)(5)(i)(A). A qualified auditor must have technical expertise obtained through education, training, or experience (or a combination thereof) necessary to perform the auditing function.