Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Form 483 issued December 20, 2019 · Los Angeles, California
- Inspection
- Dec 2 – Dec 20, 2019
- Investigator
- Erika V. Butler
- Observations
- 9
- Pages
- 19
- FEI number
- 3013341563
In short: On December 20, 2019, FDA issued a Form 483 with 9 observations to Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical in Los Angeles, California (FEI 3013341563) after an inspection that ran Dec 2 – Dec 20, 2019. The investigator was Erika V. Butler. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Employees are not given training in the particular operations they perform as part of their function…
This inspection in context
Erika V. Butler
23 documents · 2007–2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
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 211.192
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 9 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical?
Erika V. Butler is named on this Form 483, for the inspection of Dec 2 – Dec 20, 2019. 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 Dec 2 – Dec 20, 2019, and the Form 483 is dated December 20, 2019.
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.