STAQ Phann.a, Inc.
Form 483 issued September 29, 2021 · Denver, Colorado
- Inspection
- Sep 20 – Sep 29, 2021
- Investigators
- Darren S. Brown· John A. Gonzalez
- Observations
- 3
- Pages
- 3
- FEI number
- 3015144909
In short: On September 29, 2021, FDA issued a Form 483 with 3 observations to STAQ Phann.a, Inc. in Denver, Colorado (FEI 3015144909) after an inspection that ran Sep 20 – Sep 29, 2021. The investigators were Darren S. Brown and John A. Gonzalez. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 2 of 3 observations.
Most cited: 21 CFR 211.113 (1×) · 211.42 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Observation 3: scanned text, readable in the full document.
This inspection in context
Darren S. Brown
27 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at STAQ Phann.a, Inc.?
FDA listed 3 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected STAQ Phann.a, Inc.?
Darren S. Brown and John A. Gonzalez are named on this Form 483, for the inspection of Sep 20 – Sep 29, 2021. Each investigator has a profile showing what they cite most.
When was STAQ Phann.a, Inc. inspected by FDA?
The inspection ran Sep 20 – Sep 29, 2021, and the Form 483 is dated September 29, 2021.
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.