CFR section
21 CFR 113.40(g)(2)(ii)(B): Equipment and procedures
PART 113-THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS · Subpart C-Equipment
Key facts
| Citation | 21 CFR 113.40(g)(2)(ii)(B) |
|---|---|
| Section | Equipment and procedures |
| Part | PART 113-THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS |
| Subpart | Subpart C-Equipment |
| Subchapter | 21 CFR B Food |
| Product types cited | Food/Cosmetics |
| Regulation text (excerpt) | (B) Loss of sterility. A system shall be provided to stop packaging operations, or alternatively to ensure segregation of any product packaged when the packaging conditions fall below scheduled processes. Compliance with this requirement may be accomplished by diverting product away from the filler, by preventing containers from entering the filler, or by other suitable means. In the event product is packaged under conditions below those specified in the scheduled process, all such product shall… |
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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.