CFR section
21 CFR 120.12(a): Records
PART 120-HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS · Subpart A-General Provisions
Key facts
| Citation | 21 CFR 120.12(a) |
|---|---|
| Section | Records |
| Part | PART 120-HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS |
| Subpart | Subpart A-General Provisions |
| Subchapter | 21 CFR B Food |
| Product types cited | Drugs, Food/Cosmetics |
| Regulation text (excerpt) | (a) Required records. Each processor shall maintain the following records documenting the processor's Hazard Analysis and Critical Control Point (HACCP) system: (1) Records documenting the implementation of the sanitation standard operating procedures (SSOP's) (see § 120.6); (2) The written hazard analysis required by § 120.7; (3) The written HACCP plan required by § 120.8; (4) Records documenting the ongoing application of the HACCP plan that include: (i) Monitoring of critical control points… |
At a glance
- 100–999 Inspections citing this section
- 10–99 Warning letters citing this section
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.