Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3012248071.
Observations10
Issue DateSeptember 12, 2017
StatusNo Warning Letter
Establishment TypeProducer of Sterile Drug Products
Related Inspections2
Establishment Details
Firm
Maple Rose Enterprises, Inc, dba Pencol Pharmacy
Issued To
Maplerose Enterprises LLC dba Pencol Pharmacy
Location
Denver, Colorado, United States
FEI Number
3012248071
Establishment Type
Producer of Sterile Drug Products
Product Type
Drugs
Issue Date
September 12, 2017
Country
United States
Inspection History, 2016 to 2019
VAI1
OAI1
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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