FDA Inspection 1181494 — High Five Drink Inc.

High Five Drink Inc. — FEI 3017766399

The FDA completed an inspection of High Five Drink Inc. on Oct 14, 2022 in Farmers Branch, TX. 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
Oct 14, 2022
Fiscal Year
2023
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Farmers Branch, TX (United States)

Citations

IDCFRDescription
1552621 CFR 111.30(c)Equipment - automated - calibrate, inspect
1553221 CFR 111.255(b)Batch record - complete
1569821 CFR 111.320(a)Examination, testing; appropriate
1576221 CFR 111.205(a)Master manufacturing record - each batch
1582921 CFR 111.70(b)(1)Specifications - component identity
1583921 CFR 111.70(e)Specifications - identity, purity, strength, composition
1589721 CFR 111.83(a)Reserve sample - collect, hold
1595321 CFR 111.113(a)(1)Quality control production, process control; material review, disposition