CFR section
21 CFR 113.83: Establishing scheduled processes
PART 113-THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS · Subpart E-Production and Process Controls
Key facts
| Citation | 21 CFR 113.83 |
|---|---|
| Section | Establishing scheduled processes |
| Part | PART 113-THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS |
| Subpart | Subpart E-Production and Process Controls |
| Subchapter | 21 CFR B Food |
| Product types cited | Drugs, Food/Cosmetics, Veterinary |
| Regulation text (excerpt) | Scheduled processes for low-acid foods shall be established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers and having adequate facilities for making such determinations. The type, range, and combination of variations encountered in commercial production shall be adequately provided for in establishing the scheduled process. Variations include those that occur due to seasonal or growing fluctuations, variety… |
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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.