STAQ Phann.a, Inc.
Form 483 issued September 3, 2020 · Denver, Colorado
- Inspection
- Aug 25 – Sep 3, 2020
- Investigator
- Michael A. Charles
- Observations
- 5
- Pages
- 5
- FEI number
- 3015144909
In short: On September 3, 2020, FDA issued a Form 483 with 5 observations to STAQ Phann.a, Inc. in Denver, Colorado (FEI 3015144909) after an inspection that ran Aug 25 – Sep 3, 2020. The investigator was Michael A. Charles. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 3 of 5 observations.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies do not always include…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Aseptic processing areas are deficient regarding the system for cleaning an d disinfecting the room and…
This inspection in context
Michael A. Charles
29 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
The firmSTAQ Phann.a, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at STAQ Phann.a, Inc.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, quality system 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 STAQ Phann.a, Inc.?
Michael A. Charles is named on this Form 483, for the inspection of Aug 25 – Sep 3, 2020. Each investigator has a profile showing what they cite most.
When was STAQ Phann.a, Inc. inspected by FDA?
The inspection ran Aug 25 – Sep 3, 2020, and the Form 483 is dated September 3, 2020.
How do I get the full Form 483 for STAQ Phann.a, Inc.?
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.