SANTHIGRAM KERALA AYURVEDIC CO. OF US INC FDA Record
- Latest inspection NAI · Mar 26, 2026
- Last warning letter 2022
SANTHIGRAM KERALA AYURVEDIC CO. OF US INC has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to SANTHIGRAM KERALA AYURVEDIC CO. OF US INC, the most recent on May 19, 2022.
- Latest inspection
- Mar 26, 2026 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 2 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
SANTHIGRAM KERALA AYURVEDIC CO. OF US INC: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 1 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 1 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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SANTHIGRAM KERALA AYURVEDIC CO. OF US INC FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| May 19, 2022 · Record page |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 26, 2026 | Edison, NJ | Food/Cosmetics | No Action Indicated (NAI) | 3014227710 |
| Jun 7, 2023 | Edison, NJ | Food/Cosmetics | No Action Indicated (NAI) | 3014227710 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under SANTHIGRAM KERALA AYURVEDIC CO. OF US INC: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3014227710 | Edison, NJ | 2 | Mar 26, 2026 |
SANTHIGRAM KERALA AYURVEDIC CO. OF US INC and the FDA: common questions
Has SANTHIGRAM KERALA AYURVEDIC CO. OF US INC received an FDA warning letter?
Yes. FDA has issued 1 warning letter to SANTHIGRAM KERALA AYURVEDIC CO. OF US INC. The most recent is dated May 19, 2022.
Has SANTHIGRAM KERALA AYURVEDIC CO. OF US INC received an FDA Form 483?
FDA has not published a Form 483 for "SANTHIGRAM KERALA AYURVEDIC CO. OF US INC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect SANTHIGRAM KERALA AYURVEDIC CO. OF US INC?
The most recent FDA inspection on file ended Mar 26, 2026 at Edison, NJ and was classified NAI. FDA has 2 inspections of SANTHIGRAM KERALA AYURVEDIC CO. OF US INC on file.
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