Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Form 483 issued March 23, 2017 · Los Angeles, California
- Inspection
- Mar 13 – Mar 23, 2017
- Investigators
- Linda F. Murphy· Taicbun Qin
- Observations
- 8
- Pages
- 7
- FEI number
- 3013341563
In short: On March 23, 2017, FDA issued a Form 483 with 8 observations to Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical in Los Angeles, California (FEI 3013341563) after an inspection that ran Mar 13 – Mar 23, 2017. The investigators were Linda F. Murphy and Taicbun Qin. Most observations concern production and packaging & labeling; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.113 (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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Drug product containers and closures were not sterilized and processed to remove pyrogenic properties to assure…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Linda F. Murphy
23 documents · 2015–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in India.
The firmFusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical history
All 5 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 Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical?
FDA listed 8 observations on this Form 483, mostly about production, packaging & labeling 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 Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical?
Linda F. Murphy and Taicbun Qin are named on this Form 483, for the inspection of Mar 13 – Mar 23, 2017. Each investigator has a profile showing what they cite most.
When was Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical inspected by FDA?
The inspection ran Mar 13 – Mar 23, 2017, and the Form 483 is dated March 23, 2017.
How do I get the full Form 483 for Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical?
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.