FDA Inspection 874023 — Evangelical Christian Ministry dba Health & Herbs

Evangelical Christian Ministry dba Health & Herbs — FEI 3004006654

The FDA completed an inspection of Evangelical Christian Ministry dba Health & Herbs on April 2, 2014 in Houston, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 2, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Unapproved and Misbranded Drugs
Location
Houston, TX (United States)

Citations

IDCFRDescription
1538121 CFR 111.8Written procedures - hygienic practices
1549121 CFR 111.25Equipment - procedures
1553121 CFR 111.255(a)Batch record - every batch
1576221 CFR 111.205(a)Master manufacturing record - each batch
1581921 CFR 111.55Production, process controls - implement
1582921 CFR 111.70(b)(1)Specifications - component identity
1583021 CFR 111.70(b)(2)Specifications-component purity, strength, composition
1584121 CFR 111.70(f)Specifications - product received for packaging, labeling
1585821 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
1589721 CFR 111.83(a)Reserve sample - collect, hold