PT. Era Mandiri Cemerlang FDA Record
- Latest inspection NAI · May 22, 2019
- No warning letters matched by name
PT. Era Mandiri Cemerlang has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "PT. Era Mandiri Cemerlang" is on file.
- Latest inspection
- May 22, 2019 · 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 | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 22, 2019 | Jakarta, Indonesia | Food/Cosmetics | No Action Indicated (NAI) | 3004261856 |
| May 20, 2011 | Jakarta, Indonesia | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3004261856 |
- 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 3004261856 | Jakarta, Indonesia | 2 | May 22, 2019 |
PT. Era Mandiri Cemerlang and the FDA: common questions
Has PT. Era Mandiri Cemerlang received an FDA warning letter?
No FDA warning letter addressed to the name "PT. Era Mandiri Cemerlang" 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 PT. Era Mandiri Cemerlang received an FDA Form 483?
FDA has not published a Form 483 for "PT. Era Mandiri Cemerlang" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect PT. Era Mandiri Cemerlang?
The most recent FDA inspection on file ended May 22, 2019 at Jakarta, Indonesia and was classified NAI. FDA has 2 inspections of PT. Era Mandiri Cemerlang on file.
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