High Chemical Company, Div Of National Generic Distributors FDA Record
- Latest inspection OAI · Feb 8, 2019
- Last warning letter 2019
High Chemical Company, Div Of National Generic Distributors has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to High Chemical Company, Div Of National Generic Distributors, the most recent on Jul 2, 2019.
- Latest inspection
- Feb 8, 2019 · OAI
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 | 5 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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High Chemical Company, Div Of National Generic Distributors FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Jul 2, 2019 · Record page |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Feb 8, 2019 | Levittown, PA | Drugs | Official Action Indicated (OAI) | 2511349 |
| Jul 6, 2016 | Levittown, PA | Veterinary | Voluntary Action Indicated (VAI) | 2511349 |
| Sep 5, 2014 | Levittown, PA | Drugs | Voluntary Action Indicated (VAI) | 2511349 |
| Sep 7, 2012 | Levittown, PA | Drugs | Voluntary Action Indicated (VAI) | 2511349 |
| Dec 3, 2008 | Levittown, PA | Drugs | Voluntary Action Indicated (VAI) | 2511349 |
- 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 High Chemical Company, Div Of National Generic Distributors: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 2511349 | Levittown, PA | 5 | Feb 8, 2019 |
High Chemical Company, Div Of National Generic Distributors and the FDA: common questions
Has High Chemical Company, Div Of National Generic Distributors received an FDA warning letter?
Yes. FDA has issued 1 warning letter to High Chemical Company, Div Of National Generic Distributors. The most recent is dated Jul 2, 2019.
Has High Chemical Company, Div Of National Generic Distributors received an FDA Form 483?
FDA has not published a Form 483 for "High Chemical Company, Div Of National Generic Distributors" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect High Chemical Company, Div Of National Generic Distributors?
The most recent FDA inspection on file ended Feb 8, 2019 at Levittown, PA and was classified OAI. FDA has 5 inspections of High Chemical Company, Div Of National Generic Distributors on file, 1 of them classified OAI (official action indicated).
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