Sterigenics Costa Rica S.R.L. FDA Record
Sterigenics Costa Rica S.R.L. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Sterigenics Costa Rica S.R.L." is on file.
- Latest inspection
- Nov 14, 2024 · NAI
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 | 3 | 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 |
|---|---|---|---|---|
| Nov 14, 2024 | Alajuela, Costa Rica | Devices | No Action Indicated (NAI) | 3010432890 |
| Nov 16, 2017 | Alajuela, Costa Rica | Devices | No Action Indicated (NAI) | 3010432890 |
| Feb 10, 2015 | Alajuela, Costa Rica | Devices | No Action Indicated (NAI) | 3010432890 |
- 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 3010432890 | Alajuela, Costa Rica | 3 | Nov 14, 2024 |
Sterigenics Costa Rica S.R.L. and the FDA: common questions
Has Sterigenics Costa Rica S.R.L. received an FDA warning letter?
No FDA warning letter addressed to the name "Sterigenics Costa Rica S.R.L." 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 Sterigenics Costa Rica S.R.L. received an FDA Form 483?
FDA has not published a Form 483 for "Sterigenics Costa Rica S.R.L." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Sterigenics Costa Rica S.R.L.?
The most recent FDA inspection on file ended Nov 14, 2024 at Alajuela, Costa Rica and was classified NAI. FDA has 3 inspections of Sterigenics Costa Rica S.R.L. on file.
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