OUTIN FUTURES CORP.
Form 483 issued August 12, 2022 · Chungju, South Korea
- Inspection
- Aug 8 – Aug 12, 2022
- Investigator
- Sonya M. Edmonds
- Observations
- 7
- Pages
- 4
- FEI number
- 3011572099
In short: On August 12, 2022, FDA issued a Form 483 with 7 observations to OUTIN FUTURES CORP. in Chungju, Chungcheongbuk-do (FEI 3011572099) after an inspection that ran Aug 8 – Aug 12, 2022. The investigator was Sonya M. Edmonds. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and production account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Employees are not given training in…
- 02
Accelerated stability studies, combined with basic stability information, used to support tentative expiration dates are not…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures…
- 04
EIPLOYEE(S) SIGNATURE (the Republic of) In-process materials are not tested for and approved or rejected by…
This inspection in context
Sonya M. Edmonds
12 documents · 2016–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in North Carolina.
The firmOUTIN FUTURES CORP. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.25(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at OUTIN FUTURES CORP.?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, production and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected OUTIN FUTURES CORP.?
Sonya M. Edmonds is named on this Form 483, for the inspection of Aug 8 – Aug 12, 2022. Each investigator has a profile showing what they cite most.
When was OUTIN FUTURES CORP. inspected by FDA?
The inspection ran Aug 8 – Aug 12, 2022, and the Form 483 is dated August 12, 2022.
How do I get the full Form 483 for OUTIN FUTURES CORP.?
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