FDA Inspection 857993 — Healthwest Minerals Inc

Healthwest Minerals Inc — FEI 3020852

The FDA completed an inspection of Healthwest Minerals Inc on December 6, 2013 in Chehalis, WA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 21 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
December 6, 2013
Fiscal Year
2014
Product Type
Food/Cosmetics
Project Area
Foodborne Biological Hazards
Location
Chehalis, WA (United States)

Citations

IDCFRDescription
1553921 CFR 111.260(a)(1)Batch record - control number, finished batch
1554321 CFR 111.260(c)Batch record - date, time; maintenance
1554721 CFR 111.260(g)Batch record - results; monitoring
1554921 CFR 111.260(i)Batch record - specifications
1555321 CFR 111.260(j)(2)(i)Batch record - initials; weighing
1555421 CFR 111.260(j)(2)(ii)Batch record - initials; verifying weight
1555521 CFR 111.260(j)(2)(iii)Batch record - initials; component
1555621 CFR 111.260(j)(2)(iv)Batch record - initials; verifying component
1555821 CFR 111.260(k)(1)Batch record - identifier; packaging
1555921 CFR 111.260(k)(1)Batch record - identifier; labels
1556121 CFR 111.260(k)(3)Batch record - tests, examinations; results
1556721 CFR 111.260(l)(4)Batch record - approved, released, rejected
1565921 CFR 111.475(b)(1)Written procedures - holding; distributing
1573721 CFR 111.210(h)(5)Corrective action plans
1573921 CFR 111.210(h)(3)(ii)(B)Components; add, verify
1574021 CFR 111.210(h)(3)(ii)(A)Instructions; components; weight, measure
1574421 CFR 111.210(h)(2)Master manufacturing record - sampling, tests, examinations
1579621 CFR 111.430(b)Records - packaging, labeling operations
1584121 CFR 111.70(f)Specifications - product received for packaging, labeling
1585821 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
1586121 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier