Global Medical Production Co.. Ltd
Form 483 issued April 30, 2015 · Jiaxing, China
- Inspection
- Apr 27 – Apr 30, 2015
- Investigator
- Roy Baby
- Observations
- 5
- Pages
- 4
- FEI number
- 3006897899
In short: On April 30, 2015, FDA issued a Form 483 with 5 observations to Global Medical Production Co.. Ltd in Jiaxing, China (FEI 3006897899) after an inspection that ran Apr 27 – Apr 30, 2015. The investigator was Roy Baby. Most observations concern cAPA and production & process controls.
At a glance
CAPA and production & process controls account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The written MDR Procedure does not include an internal system which provides for the timely and…
- 02
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 03
Procedures for corrective and preventive act on have not…
- 04
There is no agreement with suppliers and contractors to notify you of changes in…
This inspection in context
Roy Baby
3 documents · 2015–2025
Cites 803.17 (what are the requirements for developing, maintaining, and implementing written mdr procedures that apply to me?) more than any other section. Most of their documents are for sites in Texas.
The firmGlobal Medical Production Co.. Ltd history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Global Medical Production Co.. Ltd?
FDA listed 5 observations on this Form 483, mostly about cAPA, production & process controls and design controls. The opening words of each observation are shown on this page.
Who inspected Global Medical Production Co.. Ltd?
Roy Baby is named on this Form 483, for the inspection of Apr 27 – Apr 30, 2015. Each investigator has a profile showing what they cite most.
When was Global Medical Production Co.. Ltd inspected by FDA?
The inspection ran Apr 27 – Apr 30, 2015, and the Form 483 is dated April 30, 2015.
How do I get the full Form 483 for Global Medical Production 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.