FDA Inspection 1056177 — ASA Universal Inc. dba: Sonage
The FDA completed an inspection of ASA Universal Inc. dba: Sonage on June 19, 2018 in Santa Monica, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 19, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Santa Monica, 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 |
| 1725 | 21 CFR 211.134(c) | Examinations documented |
| 1770 | 21 CFR 211.137(d) | Expiration date location on labeling |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |