SHISEIDO AMERICA INC. FDA Record
SHISEIDO AMERICA INC. has 5 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "SHISEIDO AMERICA INC." is on file.
- Latest recall
- D-0214-2018 · Class II · Dec 14, 2017
- Latest inspection
- Dec 3, 2024 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 5 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 6 | 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 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 5 | 0 |
Reviewing SHISEIDO AMERICA INC. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check SHISEIDO AMERICA INC. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0214-2018 | Class II | bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide 4.1%), 40… | Dec 14, 2017 |
| D-0215-2018 | Class II | Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone… | Dec 14, 2017 |
| D-0218-2018 | Class II | Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+ (octinoxate 4.9%, octocrylebe… | Dec 14, 2017 |
| D-0217-2018 | Class II | Shiseido Future Solution LX Luxurious Eye & Lip Collection contains SPF 50+ (octinoxate 4.9%… | Dec 14, 2017 |
| D-0216-2018 | Class II | Shiseido Future Solution LX Discovery Set contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%… | Dec 14, 2017 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Dec 3, 2024 | East Windsor, NJ | Drugs | Voluntary Action Indicated (VAI) | 3002653086 |
| Nov 1, 2018 | East Windsor, NJ | Drugs | Voluntary Action Indicated (VAI) | 3002653086 |
| Jan 26, 2017 | East Windsor, NJ | Drugs | Voluntary Action Indicated (VAI) | 3002653086 |
| May 13, 2014 | East Windsor, NJ | Drugs | Voluntary Action Indicated (VAI) | 3002653086 |
| Apr 12, 2012 | East Windsor, NJ | Drugs | No Action Indicated (NAI) | 3002653086 |
| Nov 24, 2009 | East Windsor, NJ | Drugs | No Action Indicated (NAI) | 3002653086 |
- 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 3002653086 | East Windsor, NJ | 6 | Dec 3, 2024 |
SHISEIDO AMERICA INC. and the FDA: common questions
Has SHISEIDO AMERICA INC. received an FDA warning letter?
No FDA warning letter addressed to the name "SHISEIDO AMERICA INC." 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 SHISEIDO AMERICA INC. received an FDA Form 483?
FDA has not published a Form 483 for "SHISEIDO AMERICA INC." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect SHISEIDO AMERICA INC.?
The most recent FDA inspection on file ended Dec 3, 2024 at East Windsor, NJ and was classified VAI. FDA has 6 inspections of SHISEIDO AMERICA INC. on file.
Has SHISEIDO AMERICA INC. had an FDA recall?
Yes. SHISEIDO AMERICA INC. has 5 FDA recalls on record. The most recent started Dec 14, 2017.
Need more than this page shows? Ask about SHISEIDO AMERICA INC. in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.