Morgan Gallacher, Inc DBA Custom
Amended 483 issued October 30, 2024 · Santa Fe Springs, California
- Inspection
- Oct 21 – Oct 30, 2024
- Investigators
- Darren S. Brown· Lena Nguyen
- Observations
- 1
- Pages
- 6
- FEI number
- 2022194
In short: On October 30, 2024, FDA issued a Amended 483 with 1 observation to Morgan Gallacher, Inc DBA Custom in Santa Fe Springs, California (FEI 2022194) after an inspection that ran Oct 21 – Oct 30, 2024. The investigators were Darren S. Brown and Lena Nguyen. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this amended 483 concern production.
Most cited: 21 CFR 211.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
The full amended 483
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Darren S. Brown
27 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmMorgan Gallacher, Inc DBA Custom history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar documentsOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Morgan Gallacher, Inc DBA Custom?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Morgan Gallacher, Inc DBA Custom?
Darren S. Brown and Lena Nguyen are named on this Amended 483, for the inspection of Oct 21 – Oct 30, 2024. Each investigator has a profile showing what they cite most.
When was Morgan Gallacher, Inc DBA Custom inspected by FDA?
The inspection ran Oct 21 – Oct 30, 2024, and the Amended 483 is dated October 30, 2024.
How do I get the full Amended 483 for Morgan Gallacher, Inc DBA Custom?
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.