Fresenius Medical Care de Mexico - Dec. 4, 2018
Issue Date
Dec 04, 2018
Region
HQ
Category
Drug
$117.00
Contact Name
Oscar Acosta Ramirez
Contact Title
Plant Director
Address 1
Paseo Del Norte 5300, Guadalajara Technology Park
City
Zapopan
State
Jalisco
Zip/Postal Code
45010
Country
Mexico
Inspection Range
Nov 26, 2018 - Dec 04, 2018
Pages
5
First Observation
Investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product.
Investigator(s): Latorie S. Jones