FDA Inspection 1255907 — Ethical Nutritional, LLC

Ethical Nutritional, LLC — FEI 3001452120

The FDA completed an inspection of Ethical Nutritional, LLC on Dec 5, 2024 in Pomona, CA. 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). 7 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Dec 5, 2024
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Pomona, CA (United States)

Citations

IDCFRDescription
109821 CFR 211.22(c)Approve or reject procedures or specs
113621 CFR 211.25(c)Inadequate number of personnel
117721 CFR 211.63Equipment Design, Size and Location
136121 CFR 211.100(a)Absence of Written Procedures
191421 CFR 211.166(a)Lack of written stability program
439121 CFR 211.180(e)(2)Items to cover on annual reviews
457621 CFR 211.192No written record of investigation

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