21 CFR 211.115
Reprocessing procedures not written or followed
- Inspections citing it: 100
- Of those classified, ended OAI: 31%
- Last cited: FY2026
Inspections Citing It by Fiscal Year
Sites in and outside the US, FY2017 to Oct 20, 2026.
Paragraphs Cited
As FDA posts them, all years.
- 211.115(a)
- 85 · Reprocessing procedures not written or followed
- 211.115(b)
- 15 · Reprocessing/quality control unit
Regulation Text
eCFR did not answer; open it on eCFRRecently Cited Sites
Newest inspections citing this section; each opens the site- The Procter & Gamble Manufacturing CompanyUnited States · Jun 9, 2026
- GVS TM, IncUnited States · May 1, 2026
- Nitro Quimica CorporationUnited States · Feb 21, 2025
- Rite-Kem IncorporatedUnited States · Sep 12, 2024
- Prime Enterprises LLCUnited States · Sep 1, 2023
- Safecor Health, LLCUnited States · Sep 1, 2023
- ABC Compounding Co., Inc.United States · Apr 21, 2023
- Wong Lap Kwong Medicine Company LimitedUnknown · Sep 22, 2017
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