Gotha Cosmetics Srl FDA Record
Gotha Cosmetics Srl has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Gotha Cosmetics Srl" is on file.
- Latest inspection
- Mar 1, 2024 · 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 | 2 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 1, 2024 | Lallio, Italy | Drugs | Voluntary Action Indicated (VAI) | 3005849473 |
| Sep 22, 2017 | Lallio, Italy | Drugs | No Action Indicated (NAI) | 3005849473 |
- 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 3005849473 | Lallio, Italy | 2 | Mar 1, 2024 |
Gotha Cosmetics Srl and the FDA: common questions
Has Gotha Cosmetics Srl received an FDA warning letter?
No FDA warning letter addressed to the name "Gotha Cosmetics Srl" 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 Gotha Cosmetics Srl received an FDA Form 483?
FDA has not published a Form 483 for "Gotha Cosmetics Srl" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Gotha Cosmetics Srl?
The most recent FDA inspection on file ended Mar 1, 2024 at Lallio, Italy and was classified VAI. FDA has 2 inspections of Gotha Cosmetics Srl on file.
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