National Chemical Laboratories FDA Record
National Chemical Laboratories has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to National Chemical Laboratories, the most recent on Nov 8, 2023.
- Latest inspection
- May 26, 2023 · OAI
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 | 2 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 1 | 1 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 1 | 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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National Chemical Laboratories FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Nov 8, 2023 · Letter on fda.gov | CGMP/Finished Pharmaceuticals/Adulterated | Office of Pharmaceutical Quality Operations |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 26, 2023 | Philadelphia, PA | Drugs | Official Action Indicated (OAI) | 1000071237 |
| Nov 4, 2021 | Philadelphia, PA | Drugs | Official Action Indicated (OAI) | 1000071237 |
- 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 National Chemical Laboratories: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1000071237 | Philadelphia, PA | 2 | May 26, 2023 |
National Chemical Laboratories and the FDA: common questions
Has National Chemical Laboratories received an FDA warning letter?
Yes. FDA has issued 1 warning letter to National Chemical Laboratories. The most recent is dated Nov 8, 2023, with the subject "CGMP/Finished Pharmaceuticals/Adulterated".
Has National Chemical Laboratories received an FDA Form 483?
FDA has not published a Form 483 for "National Chemical Laboratories" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect National Chemical Laboratories?
The most recent FDA inspection on file ended May 26, 2023 at Philadelphia, PA and was classified OAI. FDA has 2 inspections of National Chemical Laboratories on file, 2 of them classified OAI (official action indicated).
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