FDA Inspection 709086 — Creation's Garden Natural Products, Inc.
The FDA completed an inspection of Creation's Garden Natural Products, Inc. on January 28, 2011 in Valencia, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 28, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Valencia, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 15443 | 21 CFR 111.15(b)(2) | Physical plant - repair |
| 15505 | 21 CFR 111.27(a)(3)(v) | Equipment - protect from contamination |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15944 | 21 CFR 111.105(i) | QC - required operations master manufacturing/batch records |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |