Schlotterbeck & Foss, LLC FDA Inspection Record
Schlotterbeck & Foss, LLC is an FDA-inspected facility (FEI 1210017) located in Westbrook, ME, US. RegDataLab tracks 8 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- May 5, 2026: No Action Indicated (NAI)
- Inspections on record
- 8 (2 VAI, 6 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 2, latest Mar 20, 2021
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 5, 2026 | No Action Indicated (NAI) | No citations listed |
| Dec 23, 2021 | No Action Indicated (NAI) | No citations listed |
| Jun 4, 2019 | Voluntary Action Indicated (VAI) | Training--operations, GMPs, written procedures (21 CFR 211.25(a)) Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) Absence of Written Procedures (21 CFR 211.100(a)) Component identity verification (21 CFR 211.84(d)(1)) and 5 more |
| Dec 18, 2017 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Defined areas of adequate size for operations (21 CFR 211.42(c)) Component addition checked by 2nd person (21 CFR 211.101(d)) Retest of approved components/containers/closures (21 CFR 211.87) and 7 more |
| Sep 18, 2017 | No Action Indicated (NAI) | No citations listed |
| Jan 14, 2014 | No Action Indicated (NAI) | No citations listed |
| Feb 23, 2012 | No Action Indicated (NAI) | No citations listed |
| Dec 8, 2008 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Mar 20, 2021 | Class I | F-0391-2021 | Taste of Inspirations Garlic Parmesan Wing Sauce Contains undeclared fish |
| Dec 21, 2017 | Class II | V-0087-2018 | MediGel FBZ 4 oz.
The cups are inside a cardboard box with protection barrier for… One lot of product had sub-potent assay results. |
FDA record score
8 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.
4 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Class I recall F-0391-2021, this FEI as the recalling firm | Mar 20, 2021 | 15 x 0.25 | 3.8 |
| Inspection classified VAI | Jun 4, 2019 | 6 x 0.25 | 1.5 |
| Inspection classified VAI | Dec 18, 2017 | 6 x 0.25 | 1.5 |
| Class II recall V-0087-2018, this FEI as the recalling firm | Dec 21, 2017 | 4 x 0.25 | 1 |
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 |
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Facility details
- Company
- Schlotterbeck & Foss, LLC
- Location
- Westbrook, ME (US)
- Source
- inspections