ST Pharm Co., Ltd.
Form 483 issued November 8, 2018 · Siheung-si, South Korea
- Investigator
- Michael A. Charles
- Observations
- 3
- Pages
- 2
- FEI number
- 3004161413
In short: On November 8, 2018, FDA issued a Form 483 with 3 observations to ST Pharm Co., Ltd. in Siheung-si, Gyeonggi-do (FEI 3004161413). The investigator was Michael A. Charles. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Process validation does not always include inclusion and establishment of all process parameters that should be…
- 02
Written records of investigations into unexplained discrepancies…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate procedures designed to assure…
This inspection in context
Michael A. Charles
29 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
The firmST Pharm Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ST Pharm Co., Ltd.?
FDA listed 3 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected ST Pharm Co., Ltd.?
Michael A. Charles is named on this Form 483. Each investigator has a profile showing what they cite most.
When was ST Pharm Co., Ltd. inspected by FDA?
This Form 483 is dated November 8, 2018.
How do I get the full Form 483 for ST Pharm Co., Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.