Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
FDA inspection history in Los Angeles, California, 2017 to 2019
- 4
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2017: two Form 483s; 2018: one close-out letter; 2019: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19Four Form 483s and one close-out letter, at Los Angeles, California.
- 2019The longest 483 on file: 9 observations over 19 pages at Los Angeles, California.
Cited most
Across all Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical observations on file
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.192Production record review4
- 21 CFR 211.167Special testing requirements3
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.130Packaging and labeling operations2
The complete Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Los Angeles, California
Four Form 483s and one close-out letter · 2017 to 2019 · 30 observations
Latest: Form 483, Dec 20, 2019 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-12-20 | 483 Form 483 | Los Angeles, California | 9 | $99 |
| 2019-12-20 | 483 Form 483 | Los Angeles, California | 9 | $99 |
| 2018-02-21 | Close-out Close-out letter | Los Angeles, California | — | $99 |
| 2017-03-23 | 483 Form 483 | Los Angeles, California | 4 | $99 |
| 2017-03-23 | 483 Form 483 | Los Angeles, California | 8 | $99 |
Investigators on these documents
Erika V. Butler (2)Brian P. Murphy (1)Linda F. Murphy (1)Macedonio D. Doolan (1)Taicbun Qin (1)Thach-Nga Q. Luu (1)
FEI number 3013341563 · most recent document Dec 20, 2019
About Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
How many FDA Form 483s has Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical received?
FDA Intel has 4 Form 483s on file for Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical; the most recent is dated Dec 20, 2019.
When was Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical last inspected by FDA?
The most recent FDA inspection document on file for Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is a Form 483 dated Dec 20, 2019, for the site in Los Angeles, California.
What did FDA cite at Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical?
The regulations cited most in the observations on file for Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical are 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.167 (Special testing requirements), 3 times.