Central Solutions Inc FDA Inspection Record
Central Solutions Inc is an FDA-registered facility (FEI 1000138339) located in KANSAS CITY, KS, US. Registered operations: MANUFACTURE. RegDataLab tracks 6 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Apr 2, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 6 (3 VAI, 3 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
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 2, 2025 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Absence of Written Procedures (21 CFR 211.100(a)) Microbiological testing (21 CFR 211.165(b)) Valid stability test methods (21 CFR 211.166(a)(3)) and 2 more |
| Aug 15, 2023 | No Action Indicated (NAI) | No citations listed |
| Nov 21, 2019 | Voluntary Action Indicated (VAI) | Training--operations, GMPs, written procedures (21 CFR 211.25(a)) Cleaning SOPs/equipment protection (21 CFR 211.67(b)(5)) Absence of Written Procedures (21 CFR 211.100(a)) Components withheld from use pending release (21 CFR 211.84(a)) and 5 more |
| Jul 10, 2015 | Voluntary Action Indicated (VAI) | Inadequate number of personnel (21 CFR 211.25(c)) Calibration/Inspection/Checking not done (21 CFR 211.68(a)) Procedures for non-sterile drug products (21 CFR 211.113(a)) Test methods (21 CFR 211.165(e)) and 3 more |
| Apr 19, 2011 | No Action Indicated (NAI) | Complaint Investigation/Follow-Up Findings (21 CFR 211.198(b)(2)) Control procedures to monitor and validate performance (21 CFR 211.110(a)) Items to cover on annual reviews (21 CFR 211.180(e)(2)) Written record of investigation incomplete (21 CFR 211.192) |
| Apr 9, 2010 | No Action Indicated (NAI) | No citations listed |
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.
3 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Inspection classified VAI | Apr 2, 2025 | 6 x 1 | 6 |
| Inspection classified VAI | Nov 21, 2019 | 6 x 0.25 | 1.5 |
| Inspection classified VAI | Jul 10, 2015 | 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 |
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Facility details
- Company
- Central Solutions, Inc.
- Location
- KANSAS CITY, KS (US)
- Registration Expires
- Dec 31, 2026
- Operations
- MANUFACTURE
- Source
- both