FDA Inspection 627351 — Better Halfshell, Inc.

Better Halfshell, Inc. — FEI 3005251906

The FDA completed an inspection of Better Halfshell, Inc. on Nov 4, 2009 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 4, 2009
Fiscal Year
2010
Product Type
Food/Cosmetics
Project Area
Foodborne Biological Hazards
Location
San Diego, CA (United States)

Citations

IDCFRDescription
152421 CFR 123.11(b)Sanitation monitoring
152521 CFR 123.11(c)Sanitation Records
600821 CFR 123.8(a)(3)Verification - record review - frequency
600921 CFR 123.8(a)(3)(iii)Verification - record review - calibration
601621 CFR 123.6(c)(7)Records system
93321 CFR 123.8(a)(2)(ii)Calibration - adequacy
96021 CFR 123.6(c)(2)Critical control points
96321 CFR 123.6(c)(5)Corrective action plan

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