FDA Inspection 789249 — Standard Process, Inc.
The FDA completed an inspection of Standard Process, Inc. on July 2, 2012 in Palmyra, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 15 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 2, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Palmyra, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15444 | 21 CFR 111.15(c)(1) | Cleaning compounds |
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15548 | 21 CFR 111.260(h) | Batch record - results; testing, examination; batch |
| 15551 | 21 CFR 111.260(j)(1) | Batch record - date, each step |
| 15581 | 21 CFR 111.155(c)(3) | Quality control - components, approve, release |
| 15584 | 21 CFR 111.155(d)(1) | Components - identify lot produced |
| 15727 | 21 CFR 111.365(e) | Microorganism, decomposition - remove, destroy, prevent |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15749 | 21 CFR 111.210(e) | Master manufacturing record - intentional overage |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15843 | 21 CFR 111.70(g) | Specifications - finished packaging, labeling |
| 16039 | 21 CFR 111.605(c) | Records - electronic |