CFR section
21 CFR 225.102(b)(4): Master record file and production records
PART 225-CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS · Subpart E-Records and Reports
Key facts
| Citation | 21 CFR 225.102(b)(4) |
|---|---|
| Section | Master record file and production records |
| Part | PART 225-CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS |
| Subpart | Subpart E-Records and Reports |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Drugs, Veterinary |
| Regulation text (excerpt) | (4) Batch production records shall be checked by a responsible individual at the end of the working day in which the product was manufactured to determine whether all required production steps have been performed. If significant discrepancies are noted, an investigation shall be instituted immediately, and the production record shall describe the corrective action taken. |
At a glance
- 10–99 Inspections citing this section
- 1–9 Warning letters citing this section
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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.