FDA Inspection 1218672 — ELM, Inc.
The FDA completed an inspection of ELM, Inc. on September 22, 2023 in Carolina, PR. 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: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 22, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Carolina, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18141 | 21 CFR 117.35(a) | Sanitary operations - Plant maintenance |
| 22702 | 21 CFR 117.135(a)(1) | Process preventive controls - Identify (Written) |
| 22714 | 21 CFR 117.410(c) | Supply-chain program - Assurance (Adequate) |
| 22720 | 21 CFR 117.135(c)(3) | Sanitation preventive controls - Appropriate (Adequate) |