Global Pharma Healthcare Private Limited FDA Record
Global Pharma Healthcare Private Limited has 5 FDA recalls (3 Class I), 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Global Pharma Healthcare Private Limited, the most recent on Oct 20, 2023.
- Latest recall
- D-0488-2023 · Class I · Feb 24, 2023
- Latest inspection
- Mar 2, 2023 · OAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 5 (3 Class I) | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Global Pharma Healthcare Private Limited FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Oct 20, 2023 · Letter on fda.gov | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded | Center for Drug Evaluation and Research | CDER |
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0488-2023 | Class I | Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.)… | Feb 24, 2023 |
| D-0922-2023 | Class II | Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml… | Jan 30, 2023 |
| D-0919-2023 | Class I | Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15… | Jan 30, 2023 |
| D-0921-2023 | Class I | Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml… | Jan 30, 2023 |
| D-0920-2023 | Class II | Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15… | Jan 30, 2023 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 2, 2023 | Chennai, India | Drugs | Official Action Indicated (OAI) | 3012323885 |
- 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 Global Pharma Healthcare Private Limited: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3012323885 | Chennai, India | 1 | Mar 2, 2023 |
Global Pharma Healthcare Private Limited and the FDA: common questions
Has Global Pharma Healthcare Private Limited received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Global Pharma Healthcare Private Limited. The most recent is dated Oct 20, 2023, with the subject "CGMP/Finished Pharmaceuticals/Adulterated/Misbranded".
Has Global Pharma Healthcare Private Limited received an FDA Form 483?
FDA has not published a Form 483 for "Global Pharma Healthcare Private Limited" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Global Pharma Healthcare Private Limited?
The most recent FDA inspection on file ended Mar 2, 2023 at Chennai, India and was classified OAI. FDA has 1 inspection of Global Pharma Healthcare Private Limited on file, 1 of them classified OAI (official action indicated).
Has Global Pharma Healthcare Private Limited had an FDA recall?
Yes. Global Pharma Healthcare Private Limited has 5 FDA recalls on record, 3 of them Class I, the most serious class. The most recent started Feb 24, 2023.
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