FDA Inspection 938714 — Majopa Industries Corporation

Majopa Industries Corporation — FEI 3008783879

The FDA completed an inspection of Majopa Industries Corporation on August 11, 2015 in Guayama, PR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 11, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Unapproved and Misbranded Drugs
Location
Guayama, PR (United States)

Citations

IDCFRDescription
1553521 CFR 111.255(d)Batch record - 1 year, 2 years
1573621 CFR 111.353Manufacturing operations - written procedures
1576221 CFR 111.205(a)Master manufacturing record - each batch