FDA Inspection 1151795 — DSP Skin Care LLC
The FDA completed an inspection of DSP Skin Care LLC on September 9, 2021 in Los Angeles, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 9, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Los Angeles, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1770 | 21 CFR 211.137(d) | Expiration date location on labeling |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4336 | 21 CFR 211.150 | Written distribution procedure |