ACRX Specialty Pharmacy Inc.
Form 483 issued July 23, 2021 · Las Vegas, Nevada
- Inspection
- Jul 12 – Jul 23, 2021
- Investigator
- Taichun Qin
- Observations
- 7
- Pages
- 5
- FEI number
- 3015134033
In short: On July 23, 2021, FDA issued a Form 483 with 7 observations to ACRX Specialty Pharmacy Inc. in Las Vegas, Nevada (FEI 3015134033) after an inspection that ran Jul 12 – Jul 23, 2021. The investigator was Taichun Qin. 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 6 of 7 observations.
Most cited: 21 CFR 211.113 (3×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The ISO 5 classified aseptic processing areas had difficult to clean and visibly…
- 02
Non-microbial contamination was observed…
- 03
Your firm produced drug products with materials that had not been verified to assure that they…
- 04
Dynamic smoke studies are…
This inspection in context
Taichun Qin
35 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmACRX Specialty Pharmacy Inc. history
All 4 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 ACRX Specialty Pharmacy Inc.?
FDA listed 7 observations on this Form 483, mostly about production, facilities & equipment and materials. 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 ACRX Specialty Pharmacy Inc.?
Taichun Qin is named on this Form 483, for the inspection of Jul 12 – Jul 23, 2021. Each investigator has a profile showing what they cite most.
When was ACRX Specialty Pharmacy Inc. inspected by FDA?
The inspection ran Jul 12 – Jul 23, 2021, and the Form 483 is dated July 23, 2021.
How do I get the full Form 483 for ACRX Specialty Pharmacy 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.