Cosco International, Inc.
Form 483 issued October 25, 2024 · Marietta, Georgia
- Inspection
- Oct 15 – Oct 25, 2024
- Investigator
- Susan O. Oladeji
- Observations
- 9
- Pages
- 10
- FEI number
- 3000220439
In short: On October 25, 2024, FDA issued a Form 483 with 9 observations to Cosco International, Inc. in Marietta, Georgia (FEI 3000220439) after an inspection that ran Oct 15 – Oct 25, 2024. The investigator was Susan O. Oladeji. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
Each lot of a component that is liable to microbiological contamination that is objectionable in view…
- 03
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Susan O. Oladeji
15 documents · 2017–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Georgia.
The firmCosco International, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cosco International, Inc.?
FDA listed 9 observations on this Form 483, mostly about quality system, materials and production. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Cosco International, Inc.?
Susan O. Oladeji is named on this Form 483, for the inspection of Oct 15 – Oct 25, 2024. Each investigator has a profile showing what they cite most.
When was Cosco International, Inc. inspected by FDA?
The inspection ran Oct 15 – Oct 25, 2024, and the Form 483 is dated October 25, 2024.
How do I get the full Form 483 for Cosco International, Inc.?
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