LGM Pharma Solutions, LLC
FDA inspection history in Irvine, California, 2024
- 1
- Form 483
Every document, by year
- Form 483
2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One Form 483, at Irvine, California.
Cited most
Across all LGM Pharma Solutions observations on file
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.160(a)General requirements1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.67(b)Equipment cleaning and maintenance1
The complete LGM Pharma Solutions file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Irvine, California
One Form 483 · 2024 · 4 observations
Latest: Form 483, Mar 1, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-03-01 | 483 Form 483 | Irvine, California | 4 | $99 |
Investigators on these documents
Biologics X. Es (1)Biologics X. Seno (1)Biologics X. Sgro (1)
FEI number 3017140477 · most recent document Mar 1, 2024
About LGM Pharma Solutions, LLC
How many FDA Form 483s has LGM Pharma Solutions, LLC received?
FDA Intel has 1 Form 483 on file for LGM Pharma Solutions, LLC; the most recent is dated Mar 1, 2024.
When was LGM Pharma Solutions, LLC last inspected by FDA?
The most recent FDA inspection document on file for LGM Pharma Solutions, LLC is a Form 483 dated Mar 1, 2024, for the site in Irvine, California.
What did FDA cite at LGM Pharma Solutions, LLC?
The regulations cited most in the observations on file for LGM Pharma Solutions, LLC are 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.160(a) (General requirements), 1 time; 21 CFR 211.22(d) (Responsibilities of quality control unit), 1 time.