FDA Inspection 1228345 — SALEM Botanicals Corp.
The FDA completed an inspection of SALEM Botanicals Corp. on January 29, 2024 in Carneys Point, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 29, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Carneys Point, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 16064 | 21 CFR 111.35(a) | Records - equipment, utensils: readily available |