FDA Inspection 1250237 — Future Foam, Inc.
The FDA completed an inspection of Future Foam, Inc. on September 27, 2024 in San Clemente, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 27, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- San Clemente, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1978 | 21 CFR 211.182 | Personnel dating/signing equipment log |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 3591 | 21 CFR 211.110(b) | In-process materials specifications |
| 3630 | 21 CFR 211.170(b) | Drug product reserve containers |