FDA Inspection 1303324 — Carolina Liquid Chemistries Corp

Carolina Liquid Chemistries Corp — FEI 3000215862

The FDA completed an inspection of Carolina Liquid Chemistries Corp on Feb 17, 2026 in Brea, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI)
End Date
Feb 17, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Brea, CA (United States)

Citations

IDCFRDescription
23019ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
23150ISO 13485:2016 Clause 7.4.3Purchased product verification activities not established or implemented
23215ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.