FDA Inspection
SALEM Botanicals Corp.SALEM Botanicals Corp. – FDA Inspection, Feb 10, 2025
Record Details
This FDA Inspection record concerns SALEM Botanicals Corp., with an inspection on February 10, 2025, issued by the New Jersey District Office, covering foods & cosmetics.
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ID · f4fa6638-3c12-4ace-a520-f1167dd0b0e3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1260679
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling, and Economics
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 111.113(b)(2)Quality control - reject; specification not met
- 21 CFR 111.210Master manufacturing record - record requirements
- 21 CFR 111.260Batch record - required information
- 21 CFR 111.320(b)Examination, testing; scientifically valid
- 21 CFR 111.303Written procedures - follow; laboratory
- 21 CFR 111.75(a)(2)(ii)(C)Documentation - qualify supplier
- 21 CFR 111.12Personnel - qualifications
- 21 CFR 111.75(c)(3)Specifications met identity, purity, strength, comp,; basis
- 21 CFR 111.25Equipment - follow written procedures
- 21 CFR 111.453Written procedures - establish; holding and distribution
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Other FDA inspections of SALEM Botanicals Corp.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 29, 2024 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 18, 2019 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| August 18, 2017 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| July 22, 2009 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for SALEM Botanicals Corp.
- FDA Inspection 1228345 - 2024-01-29
- FDA Inspection 1102136 - 2019-09-18
- FDA Inspection 1022086 - 2017-08-18
- FDA Inspection 598728 - 2009-07-22
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