ST Pharm Co., Ltd.

FDA inspection history in Siheung-si, South Korea, 2018

1
Form 483

Every document, by year

  • Form 483

2018: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2018One Form 483, at Siheung-si, South Korea.

Cited most

Across all ST Pharm Co. observations on file

The complete ST Pharm Co. file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Sites

Documents

1 on file, newest first
DateDocumentPrice
2018-11-08483 Form 483$99

Investigators on these documents

Michael A. Charles (1)

FEI number 3004161413 · most recent document Nov 8, 2018

About ST Pharm Co., Ltd.

How many FDA Form 483s has ST Pharm Co., Ltd. received?

FDA Intel has 1 Form 483 on file for ST Pharm Co., Ltd.; the most recent is dated Nov 8, 2018.

When was ST Pharm Co., Ltd. last inspected by FDA?

The most recent FDA inspection document on file for ST Pharm Co., Ltd. is a Form 483 dated Nov 8, 2018, for the site in Siheung-si, South Korea.

What did FDA cite at ST Pharm Co., Ltd.?

The regulations cited most in the observations on file for ST Pharm Co., Ltd. are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.192 (Production record review), 1 time.