FDA Inspection 1018131 — Fito Peru Export Import SAC

Fito Peru Export Import SAC — FEI 3013377778

The FDA completed an inspection of Fito Peru Export Import SAC on Jul 13, 2017 in Pachacamac. 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). 5 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection details

Classification
Voluntary Action Indicated (VAI)
End Date
Jul 13, 2017
Fiscal Year
2017
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Pachacamac (Peru)

Citations

IDCFRDescription
1566521 CFR 111.303Written procedures - tests, examinations; specifications met
1567521 CFR 111.315(b)Sampling plans; establish, follow
1576221 CFR 111.205(a)Master manufacturing record - each batch
1583921 CFR 111.70(e)Specifications - identity, purity, strength, composition
1585821 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient

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