AMO (Hangzhou) Co., Ltd.
Form 483 issued July 2, 2019 · Hangzhou, China
- Inspection
- Jun 24 – Jul 2, 2019
- Investigator
- Jo D. Hustedt
- Observations
- 3
- Pages
- 2
- FEI number
- 3004178847
In short: On July 2, 2019, FDA issued a Form 483 with 3 observations to AMO (Hangzhou) Co., Ltd. in Hangzhou, Zhejiang (FEI 3004178847) after an inspection that ran Jun 24 – Jul 2, 2019. The investigator was Jo D. Hustedt. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production 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
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Jo D. Hustedt
1 document · 2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in China.
The firmAMO (Hangzhou) Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AMO (Hangzhou) Co., Ltd.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected AMO (Hangzhou) Co., Ltd.?
Jo D. Hustedt is named on this Form 483, for the inspection of Jun 24 – Jul 2, 2019. Each investigator has a profile showing what they cite most.
When was AMO (Hangzhou) Co., Ltd. inspected by FDA?
The inspection ran Jun 24 – Jul 2, 2019, and the Form 483 is dated July 2, 2019.
How do I get the full Form 483 for AMO (Hangzhou) 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.