Bio-Tech Pharmacal, Inc FDA Record
Bio-Tech Pharmacal, Inc has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Bio-Tech Pharmacal, Inc" is on file.
- Latest inspection
- Apr 11, 2025 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 6 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 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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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 11, 2025 | Fayetteville, AR | Food/Cosmetics | Voluntary Action Indicated (VAI) | 1910279 |
| Apr 21, 2021 | Fayetteville, AR | Food/Cosmetics | No Action Indicated (NAI) | 1910279 |
| Sep 14, 2016 | Fayetteville, AR | Food/Cosmetics | No Action Indicated (NAI) | 1910279 |
| Sep 14, 2016 | Fayetteville, AR | Food/Cosmetics | Voluntary Action Indicated (VAI) | 1910279 |
| Feb 2, 2011 | Fayetteville, AR | Drugs | No Action Indicated (NAI) | 1910279 |
| Nov 14, 2008 | Fayetteville, AR | Drugs | No Action Indicated (NAI) | 1910279 |
- 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.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1910279 | Fayetteville, AR | 6 | Apr 11, 2025 |
Bio-Tech Pharmacal, Inc and the FDA: common questions
Has Bio-Tech Pharmacal, Inc received an FDA warning letter?
No FDA warning letter addressed to the name "Bio-Tech Pharmacal, Inc" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Bio-Tech Pharmacal, Inc received an FDA Form 483?
FDA has not published a Form 483 for "Bio-Tech Pharmacal, Inc" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Bio-Tech Pharmacal, Inc?
The most recent FDA inspection on file ended Apr 11, 2025 at Fayetteville, AR and was classified VAI. FDA has 6 inspections of Bio-Tech Pharmacal, Inc on file.
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