FDA Inspection 770198 — Creation's Garden Natural Products, Inc.
The FDA completed an inspection of Creation's Garden Natural Products, Inc. on March 6, 2012 in Valencia, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 19 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 6, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Valencia, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 15499 | 21 CFR 111.27(a) | Equipment - design - suitable |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15702 | 21 CFR 111.320(b) | Examination, testing; scientifically valid |
| 15733 | 21 CFR 111.365 | Manufacturing operations - prevent contamination |
| 15821 | 21 CFR 111.60(a) | Production, in- process control system - design, quality |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3614 | 21 CFR 211.160(b)(4) | Written calibration procedures |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |