Morgan Gallacher, Inc DBA Custom
FDA inspection history in Santa Fe Springs, California, 2019 to 2024
- 3
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2023: one Form 483; 2024: one amended 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Santa Fe Springs, California.
- 2023–24One Form 483 and one amended 483, at Santa Fe Springs, California.
- 2023The longest 483 on file: 12 observations over 11 pages at Santa Fe Springs, California.
Cited most
Across all Morgan Gallacher, Inc DBA Custom observations on file
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.67(a)Equipment cleaning and maintenance2
- 21 CFR 211.84(a)Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.103Calculation of yield1
- 21 CFR 211.115(a)Reprocessing1
The complete Morgan Gallacher, Inc DBA Custom file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Santa Fe Springs, California
Two Form 483s and one amended 483 · 2019 to 2024 · 17 observations
Latest: Form 483, Oct 30, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-10-30 | Amended 483 Amended 483 | Santa Fe Springs, California | 1 | $99 |
| 2023-10-26 | 483 Form 483 | Santa Fe Springs, California | 12 | $99 |
| 2019-08-23 | 483 Form 483 | Santa Fe Springs, California | 4 | $99 |
Investigators on these documents
Darren S. Brown (2)Anney Lin (1)Lena Nguyen (1)Santiago Gallardo Johnson (1)
FEI number 2022194 · most recent document Oct 30, 2024
About Morgan Gallacher, Inc DBA Custom
How many FDA Form 483s has Morgan Gallacher, Inc DBA Custom received?
FDA Intel has 3 Form 483s on file for Morgan Gallacher, Inc DBA Custom; the most recent is dated Oct 30, 2024.
When was Morgan Gallacher, Inc DBA Custom last inspected by FDA?
The most recent FDA inspection document on file for Morgan Gallacher, Inc DBA Custom is a Form 483 dated Oct 30, 2024, for the site in Santa Fe Springs, California.
What did FDA cite at Morgan Gallacher, Inc DBA Custom?
The regulations cited most in the observations on file for Morgan Gallacher, Inc DBA Custom are 21 CFR 211.100(a) (Written procedures; deviations), 2 times; 21 CFR 211.67(a) (Equipment cleaning and maintenance), 2 times; 21 CFR 211.84(a) (Testing and approval or rejection of components, drug product containers, and closures), 2 times.