FDA Inspection 983015 — Soaptronic LLC
The FDA completed an inspection of Soaptronic LLC on June 23, 2016 in Lake Forest, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 23, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lake Forest, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |