Maple Rose Enterprises, Inc. dba Pencol Pharmacy
FDA inspection history across 2 sites, 2016 to 2022
- 2
- Warning letters
- 2
- Form 483s
- 1
- Close-out
Every document, by year
- Close-out
- Warning letter
- Form 483
2016: one Form 483; 2017: one warning letter; 2019: one Form 483; 2020: one warning letter; 2022: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–22Two Form 483s, two warning letters and one close-out letter, at Denver, Colorado and Colorado.
- 2019The longest 483 on file: 11 observations over 11 pages at Denver, Colorado.
Cited most
Across all Maple Rose Enterprises, Inc. dba Pencol Pharmacy observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.166Stability testing2
- 21 CFR 211.22Responsibilities of quality control unit2
The complete Maple Rose Enterprises, Inc. dba Pencol Pharmacy file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Denver, Colorado
Two Form 483s, one close-out letter and one warning letter · 2016 to 2022 · 21 observations
Latest: Close-out, Mar 10, 2022 →Colorado
One warning letter · 2020
Latest: Warning letter, Aug 18, 2020 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-03-10 | Close-out Close-out letter | Denver, Colorado | — | $99 |
| 2020-08-18 | Warning letter Warning letter | Colorado | — | $99 |
| 2019-02-26 | 483 Form 483 | Denver, Colorado | 11 | $99 |
| 2017-08-02 | Warning letter Warning letter | Denver, Colorado | — | $99 |
| 2016-08-08 | 483 Form 483 | Denver, Colorado | 10 | $99 |
Investigators on these documents
Michael E. Maselli (1)Zachary A. Bogorad (1)Zachery L. Miller (1)
FEI number 3012248071 · most recent document Mar 10, 2022
About Maple Rose Enterprises, Inc. dba Pencol Pharmacy
How many FDA Form 483s has Maple Rose Enterprises, Inc. dba Pencol Pharmacy received?
FDA Intel has 2 Form 483s on file for Maple Rose Enterprises, Inc. dba Pencol Pharmacy; the most recent is dated Feb 26, 2019.
When was Maple Rose Enterprises, Inc. dba Pencol Pharmacy last inspected by FDA?
The most recent FDA inspection document on file for Maple Rose Enterprises, Inc. dba Pencol Pharmacy is a Form 483 dated Feb 26, 2019, for the site in Denver, Colorado.
What did FDA cite at Maple Rose Enterprises, Inc. dba Pencol Pharmacy?
The regulations cited most in the observations on file for Maple Rose Enterprises, Inc. dba Pencol Pharmacy are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.42 (Design and construction features), 3 times; 21 CFR 211.165 (Testing and release for distribution), 2 times.
Has Maple Rose Enterprises, Inc. dba Pencol Pharmacy received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Maple Rose Enterprises, Inc. dba Pencol Pharmacy; the most recent is dated Aug 18, 2020.