FDA Intel

Maple Rose Enterprises, Inc. dba Pencol Pharmacy

Form 483 issued February 26, 2019 · Denver, Colorado

Inspection
Feb 11 – Feb 26, 2019
Investigators
Zachary A. Bogorad· Zachery L. Miller
Observations
11
Pages
11
FEI number
3012248071

In short: On February 26, 2019, FDA issued a Form 483 with 11 observations to Maple Rose Enterprises, Inc. dba Pencol Pharmacy in Denver, Colorado (FEI 3012248071) after an inspection that ran Feb 11 – Feb 26, 2019. The investigators were Zachary A. Bogorad and Zachery L. Miller. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

Laboratory controls and facilities & equipment account for 8 of 11 observations.

Laboratory controls4
Facilities & equipment4
Production1
Quality system1
Other1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.167(a)

    Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to…

  2. 02
    21 CFR 211.58

    Buildings used in the processing of a diu g product are not maintained in a…

  3. 03
    21 CFR 211.68(a)

    Routine calibration, inspection and checking of mechanical and electronic equipment is not performed according to a…

  4. 04
    21 CFR 211.42(c)(10)(iv)

    Aseptic processing areas are deficient regarding the system…

7 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Zachary A. Bogorad

12 documents · 2011–2020

Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Colorado.

The firm

Maple 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 483s

Other sites cited under 211.167(a)

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 11 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. 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?

Zachary A. Bogorad and Zachery L. Miller are named on this Form 483, for the inspection of Feb 11 – Feb 26, 2019. 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 Feb 11 – Feb 26, 2019, and the Form 483 is dated February 26, 2019.

How do I get the full Form 483 for Maple Rose Enterprises, Inc. dba Pencol Pharmacy?

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