Morgan Gallacher, Inc DBA Custom
Form 483 issued August 23, 2019 · Santa Fe Springs, California
- Inspection
- Aug 21 – Aug 23, 2019
- Investigator
- Santiago Gallardo Johnson
- Observations
- 4
- Pages
- 3
- FEI number
- 2022194
In short: On August 23, 2019, FDA issued a Form 483 with 4 observations to Morgan Gallacher, Inc DBA Custom in Santa Fe Springs, California (FEI 2022194) after an inspection that ran Aug 21 – Aug 23, 2019. The investigator was Santiago Gallardo Johnson. Most observations concern laboratory controls and production.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Drug products failing to meet established…
- 02
Reprocessing procedures lack the steps to be taken to insure that reprocessed batches will conform with…
- 03
Written procedures are not followed for evaluations done at least annually and including provisions for a…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Santiago Gallardo Johnson
18 documents · 2017–2023
Cites 211.192 (production record review) 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 211.165(f)
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 4 observations on this Form 483, mostly about laboratory controls, production and quality system. The opening words of each observation are shown on this page.
Who inspected Morgan Gallacher, Inc DBA Custom?
Santiago Gallardo Johnson is named on this Form 483, for the inspection of Aug 21 – Aug 23, 2019. Each investigator has a profile showing what they cite most.
When was Morgan Gallacher, Inc DBA Custom inspected by FDA?
The inspection ran Aug 21 – Aug 23, 2019, and the Form 483 is dated August 23, 2019.
How do I get the full Form 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.