1109110

Hawaii Pharm LLC — FEI 3015221743

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
November 7, 2019
Fiscal Year
2020
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Honolulu, HI (United States)

Citations

IDCFRDescription
1553121 CFR 111.255(a)Batch record - every batch
1576221 CFR 111.205(a)Master manufacturing record - each batch
1580921 CFR 111.570(b)(1)Written procedures - product complaint; review, investigate
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
1592121 CFR 111.95(b)(2)Documentation - supplier qualification