Overview
- 1 public-safe observation is available for this inspection.
- 1 structured CFR citation is represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
27 Oct 2022
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Veronica Fuentes, David J Gomes
Inspected site
SPSamchundang Pharm Co., Ltd.Hwaseong, Korea (the Republic of)
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
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- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere