FDA Inspection 848709 — Standard Process, Inc.
The FDA completed an inspection of Standard Process, Inc. on September 10, 2013 in Palmyra, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 10, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Palmyra, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15499 | 21 CFR 111.27(a) | Equipment - design - suitable |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15735 | 21 CFR 111.355 | Manufacturing operations - design |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15855 | 21 CFR 111.73 | Specifications met - received product identified |
| 15872 | 21 CFR 111.75(c)(3) | Specifications met identity,purity, strength, comp,; basis |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |