Maple Rose Enterprises, Inc. dba Pencol Pharmacy
Form 483 issued August 8, 2016 · Denver, Colorado
- Inspection
- Aug 8, 2016
- Investigator
- Michael E. Maselli
- Observations
- 10
- Pages
- 7
- FEI number
- 3012248071
In short: On August 8, 2016, FDA issued a Form 483 with 10 observations to Maple Rose Enterprises, Inc. dba Pencol Pharmacy in Denver, Colorado (FEI 3012248071) after an inspection that ran Aug 8, 2016. The investigator was Michael E. Maselli. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 6 of 10 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Routine calibration, inspection and checking of mechanical and electronic equipment is not performed according to a…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Michael E. Maselli
6 documents · 2015–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Colorado.
The firmMaple Rose Enterprises, Inc. dba Pencol Pharmacy history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Maple Rose Enterprises, Inc. dba Pencol Pharmacy?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Maple Rose Enterprises, Inc. dba Pencol Pharmacy?
Michael E. Maselli is named on this Form 483, for the inspection of Aug 8, 2016. Each investigator has a profile showing what they cite most.
When was Maple Rose Enterprises, Inc. dba Pencol Pharmacy inspected by FDA?
The inspection ran Aug 8, 2016, and the Form 483 is dated August 8, 2016.
How do I get the full Form 483 for Maple Rose Enterprises, Inc. dba Pencol Pharmacy?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.