FDA Inspection 794597 — KDS Nail Products
The FDA completed an inspection of KDS Nail Products on August 2, 2012 in Sacramento, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 2, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sacramento, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1632 | 21 CFR 211.130(c) | Lot or control number assigned |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |