Morgan Gallacher, Inc DBA Custom
Form 483 issued October 26, 2023 · Santa Fe Springs, California
- Inspection
- Oct 16 – Oct 26, 2023
- Investigators
- Anney Lin· Darren S. Brown
- Observations
- 12
- Pages
- 11
- FEI number
- 2022194
In short: On October 26, 2023, FDA issued a Form 483 with 12 observations to Morgan Gallacher, Inc DBA Custom in Santa Fe Springs, California (FEI 2022194) after an inspection that ran Oct 16 – Oct 26, 2023. The investigators were Anney Lin and Darren S. Brown. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks the responsibility and authority to approve and reject all…
- 02
An observation concerning Annual Product Review was removed based…
- 03
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 04
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate…
This inspection in context
Anney Lin
9 documents · 2023–2026
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) 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 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Morgan Gallacher, Inc DBA Custom?
FDA listed 12 observations on this Form 483, mostly about production, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Morgan Gallacher, Inc DBA Custom?
Anney Lin and Darren S. Brown are named on this Form 483, for the inspection of Oct 16 – Oct 26, 2023. Each investigator has a profile showing what they cite most.
When was Morgan Gallacher, Inc DBA Custom inspected by FDA?
The inspection ran Oct 16 – Oct 26, 2023, and the Form 483 is dated October 26, 2023.
How do I get the full Form 483 for Morgan Gallacher, Inc DBA Custom?
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