LGM Pharma Solutions, LLC
Form 483 issued March 1, 2024 · Irvine, California
- Inspection
- Feb 21 – Mar 1, 2024
- Investigators
- Biologics X. Es· Biologics X. Seno· Biologics X. Sgro
- Observations
- 4
- Pages
- 8
- FEI number
- 3017140477
In short: On March 1, 2024, FDA issued a Form 483 with 4 observations to LGM Pharma Solutions, LLC in Irvine, California (FEI 3017140477) after an inspection that ran Feb 21 – Mar 1, 2024. The investigators were Biologics X. Es, Biologics X. Seno and Biologics X. Sgro. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 03
Deviations from written test procedures and laboratory mechanisms are…
- 04
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
This inspection in context
Biologics X. Es
1 document · 2024
Cites 211.100(a) (written procedures; deviations) more than any other section. Most of their documents are for sites in California.
The firmLGM Pharma Solutions, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at LGM Pharma Solutions, LLC?
FDA listed 4 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected LGM Pharma Solutions, LLC?
Biologics X. Es, Biologics X. Seno and Biologics X. Sgro are named on this Form 483, for the inspection of Feb 21 – Mar 1, 2024. Each investigator has a profile showing what they cite most.
When was LGM Pharma Solutions, LLC inspected by FDA?
The inspection ran Feb 21 – Mar 1, 2024, and the Form 483 is dated March 1, 2024.
How do I get the full Form 483 for LGM Pharma Solutions, LLC?
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.