21 CFR 211.103
Calculation of yield.
- Inspections citing it: 167
- Of those classified, ended OAI: 23%
- Last cited: FY2026
Inspections Citing It by Fiscal Year
Sites in and outside the US, FY2017 to Oct 20, 2026.
Regulation Text
eCFR, as of Nov 6, 2026Actual yields and percentages of theoretical yield shall be determined at the conclusion of each appropriate phase of manufacturing, processing, packaging, or holding of the drug product. Such calculations shall either be performed by one person and independently verified by a second person, or, if the yield is calculated by automated equipment under § 211.68, be independently verified by one person.
Recently Cited Sites
Newest inspections citing this section; each opens the site- GVS TM, IncUnited States · May 1, 2026
- Unipharm Inc.United States · Nov 21, 2025
- Bell Pharmaceuticals, IncUnited States · Jun 18, 2025
- Soaptronic LLCUnited States · Apr 28, 2025
Counts are inspections with posted citations that cite any paragraph of the section, once per inspection, from FDA's Data Dashboard. OAI share is over inspections FDA finally classified. Text from eCFR, the official online CFR. FDA Data Dashboard and eCFR