FDA Inspection 928388 — Cedar Hill, Inc.
The FDA completed an inspection of Cedar Hill, Inc. on Jun 8, 2015 in Edmond, OK. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 8, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Edmond, OK (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15405 | 21 CFR 111.13(a) | Supervisor - qualified |
| 15493 | 21 CFR 111.25(b) | Procedures - calibrating automated, mechanical equip |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15772 | 21 CFR 111.415(g) | Representative sample - packaged, labeled dietary supplement |
| 15786 | 21 CFR 111.410(b) | Labels - issuance, use |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 1601 | 21 CFR 110.37(a) | Safe and adequate sanitary quality |