FDA Inspection 1071100 — Better Halfshell, Inc.

Better Halfshell, Inc. — FEI 3005251906

The FDA completed an inspection of Better Halfshell, Inc. on Nov 7, 2018 in San Diego, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Nov 7, 2018
Fiscal Year
2019
Product Type
Food/Cosmetics
Project Area
Foodborne Biological Hazards
Location
San Diego, CA (United States)

Citations

IDCFRDescription
600121 CFR 123.11(b)Sanitation monitoring documentation
600421 CFR 123.6(c)(4)Monitoring - adequacy
601521 CFR 123.6(c)(6)Verification procedures - none/frequency
90521 CFR 123.6(b)HACCP plan implementation
91821 CFR 123.8(a)Verification - reviewers qualifications
93321 CFR 123.8(a)(2)(ii)Calibration - adequacy
96121 CFR 123.6(c)(3)Critical limits
96321 CFR 123.6(c)(5)Corrective action plan

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