Intershell International Corp. FDA Inspection Record
Intershell International Corp. is an FDA-inspected facility (FEI 3010583758) located in Gloucester, MA, US. RegDataLab tracks 8 FDA inspections and 1 compliance action at this facility.
What FDA found at this site
- Latest inspection
- Mar 27, 2025: No Action Indicated (NAI)
- Inspections on record
- 8 (1 OAI, 4 VAI, 3 NAI)
- Last OAI inspection
- Aug 29, 2014
- Warning letters
- 1 listed by FDA for this FEI, latest Sep 26, 2014
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Mar 27, 2025 | No Action Indicated (NAI) | No citations listed |
| Mar 26, 2025 | Voluntary Action Indicated (VAI) | Sanitary operations - Plant maintenance (21 CFR 117.35(a)) Signed and dated (21 CFR 123.6(d)) Critical control points (21 CFR 123.6(c)(2)) Critical limits (21 CFR 123.6(c)(3)) |
| Dec 7, 2023 | Voluntary Action Indicated (VAI) | HACCP plan implementation (21 CFR 123.6(b)) Critical limits (21 CFR 123.6(c)(3)) |
| Dec 1, 2017 | Voluntary Action Indicated (VAI) | Monitoring - adequacy (21 CFR 123.6(c)(4)) HACCP plan implementation (21 CFR 123.6(b)) Food safety hazards (21 CFR 123.6(c)(1)) Critical limits (21 CFR 123.6(c)(3)) |
| Dec 31, 2014 | No Action Indicated (NAI) | No citations listed |
| Aug 29, 2014 | Official Action Indicated (OAI) | Sanitation monitoring (21 CFR 123.11(b)) HACCP plan implementation (21 CFR 123.6(b)) Critical control points (21 CFR 123.6(c)(2)) Critical limits (21 CFR 123.6(c)(3)) |
| Nov 26, 2013 | No Action Indicated (NAI) | No citations listed |
| Apr 7, 2010 | Voluntary Action Indicated (VAI) | Verification procedures - adequacy (21 CFR 123.6(c)(6)) Verification - record review - frequency (21 CFR 123.8(a)(3)) Corrective action per regulation (21 CFR 123.7(c)) Corrective action per predetermined plan (21 CFR 123.7(a)) and 5 more |
FDA record score
11 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
6 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Inspection classified VAI | Mar 26, 2025 | 6 x 1 | 6 |
| Inspection classified VAI | Dec 7, 2023 | 6 x 0.6 | 3.6 |
| Inspection classified VAI | Dec 1, 2017 | 6 x 0.25 | 1.5 |
| Warning letter on FDA's dashboard, which does not show close-outs | Sep 26, 2014 | 10 years or older, so it adds no points | 0 |
| Inspection classified OAI | Aug 29, 2014 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Apr 7, 2010 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
Reviewing Intershell International Corp. 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 Intershell International Corp. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Facility details
- Company
- Intershell International Corp.
- Location
- Gloucester, MA (US)
- Source
- inspections