C&T Dream Co., Ltd.
Form 483 issued November 10, 2023 · Cheonan, South Korea
- Inspection
- Nov 6 – Nov 10, 2023
- Investigator
- Robert J. Martin
- Observations
- 9
- Pages
- 6
- FEI number
- 3012668529
In short: On November 10, 2023, FDA issued a Form 483 with 9 observations to C&T Dream Co., Ltd. in Cheonan, Chungcheongnam (FEI 3012668529) after an inspection that ran Nov 6 – Nov 10, 2023. The investigator was Robert J. Martin. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Facilities & equipment and laboratory controls account for 6 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory records are deficient in that they do not include a complete record of all…
- 02
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 03
Where data from accelerated studies was used to project a tentative expiration date beyond a date…
- 04
(the Republic of) Written procedures are not followed for the cleaning and maintenance of equipment, including…
This inspection in context
Robert J. Martin
29 documents · 2014–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
The firmC&T Dream Co., Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194(a)(4)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at C&T Dream Co., Ltd.?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, laboratory controls and materials. 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 C&T Dream Co., Ltd.?
Robert J. Martin is named on this Form 483, for the inspection of Nov 6 – Nov 10, 2023. Each investigator has a profile showing what they cite most.
When was C&T Dream Co., Ltd. inspected by FDA?
The inspection ran Nov 6 – Nov 10, 2023, and the Form 483 is dated November 10, 2023.
How do I get the full Form 483 for C&T Dream Co., Ltd.?
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