ACRX Specialty Pharmacy Inc.
Form 483 issued March 20, 2019 · Las Vegas, Nevada
- Inspection
- Feb 25 – Mar 20, 2019
- Investigator
- Bryan L. McGuckin
- Observations
- 9
- Pages
- 8
- FEI number
- 3015134033
In short: On March 20, 2019, FDA issued a Form 483 with 9 observations to ACRX Specialty Pharmacy Inc. in Las Vegas, Nevada (FEI 3015134033) after an inspection that ran Feb 25 – Mar 20, 2019. The investigator was Bryan L. McGuckin. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and facilities & equipment account for 6 of 9 observations.
Most cited: 21 CFR 211.165 (2×)
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…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
There is no written testing program designed to assess the stability…
- 04
The distribution system is deficient in that each lot of drug product cannot be readily determined…
This inspection in context
Bryan L. McGuckin
30 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
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 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ACRX Specialty Pharmacy Inc.?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected ACRX Specialty Pharmacy Inc.?
Bryan L. McGuckin is named on this Form 483, for the inspection of Feb 25 – Mar 20, 2019. Each investigator has a profile showing what they cite most.
When was ACRX Specialty Pharmacy Inc. inspected by FDA?
The inspection ran Feb 25 – Mar 20, 2019, and the Form 483 is dated March 20, 2019.
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.