Sinsin Pharmaceutical Co., Ltd.
Form 483 issued December 13, 2019 · Sejong, South Korea
- Inspection
- Dec 9 – Dec 13, 2019
- Investigator
- Stephanie A. Slater
- Observations
- 4
- Pages
- 7
- FEI number
- 3002277609
In short: On December 13, 2019, FDA issued a Form 483 with 4 observations to Sinsin Pharmaceutical Co., Ltd. in Sejong, South Korea (FEI 3002277609) after an inspection that ran Dec 9 – Dec 13, 2019. The investigator was Stephanie A. Slater. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test…
- 03
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Stephanie A. Slater
20 documents · 2015–2021
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in California.
The firmSinsin Pharmaceutical 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sinsin Pharmaceutical Co., Ltd.?
FDA listed 4 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Sinsin Pharmaceutical Co., Ltd.?
Stephanie A. Slater is named on this Form 483, for the inspection of Dec 9 – Dec 13, 2019. Each investigator has a profile showing what they cite most.
When was Sinsin Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Dec 9 – Dec 13, 2019, and the Form 483 is dated December 13, 2019.
How do I get the full Form 483 for Sinsin Pharmaceutical 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.