FDA Inspection 929374 — Universal Formulas, Inc.
The FDA completed an inspection of Universal Formulas, Inc. on June 1, 2015 in Kalamazoo, MI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 15 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 1, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Kalamazoo, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15607 | 21 CFR 111.165(c)(2) | Product received - quality control; documentation; specs |
| 15652 | 21 CFR 111.465(b) | Retain reserve samples - 1 year, 2 years |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15786 | 21 CFR 111.410(b) | Labels - issuance, use |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15842 | 21 CFR 111.70(f) | Specifications - product received for packaging, labeling |
| 15843 | 21 CFR 111.70(g) | Specifications - finished packaging, labeling |
| 15878 | 21 CFR 111.75(e) | Product - visually examine, identified |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |