1 umisGloh.il Pharmaceuticals Co.. Ltd
Form 483 issued September 28, 2016 · Wuhan. Hubei, China
- Inspection
- Sep 26 – Sep 28, 2016
- Investigator
- Stephanie A. Slater
- Observations
- 9
- Pages
- 6
- FEI number
- 3010280514
In short: On September 28, 2016, FDA issued a Form 483 with 9 observations to 1 umisGloh.il Pharmaceuticals Co.. Ltd in Wuhan. Hubei, Hubei (FEI 3010280514) after an inspection that ran Sep 26 – Sep 28, 2016. The investigator was Stephanie A. Slater. Most observations concern facilities & equipment and quality system.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit does not exercise the authority to review production and control records to…
- 02
the firm's production and control records do not document Quality…
- 03
The firm uses equipment that…
- 04
the firm does not monitor the temperature and humidity of the…
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 firm1 umisGloh.il Pharmaceuticals 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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at 1 umisGloh.il Pharmaceuticals Co.. Ltd?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, quality system and materials. The opening words of each observation are shown on this page.
Who inspected 1 umisGloh.il Pharmaceuticals Co.. Ltd?
Stephanie A. Slater is named on this Form 483, for the inspection of Sep 26 – Sep 28, 2016. Each investigator has a profile showing what they cite most.
When was 1 umisGloh.il Pharmaceuticals Co.. Ltd inspected by FDA?
The inspection ran Sep 26 – Sep 28, 2016, and the Form 483 is dated September 28, 2016.
How do I get the full Form 483 for 1 umisGloh.il Pharmaceuticals 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.