Milbar Laboratories, Inc. - Nov. 27, 2022
Issue Date
Oct 26, 2022
Region
Northeast
Category
Drug
$117.00
Contact Name
Richard P. Dantas
Contact Title
CEO
Address 1
20 Commerce St.
City
East Haven
State
CT
Zip/Postal Code
06512-4145
Inspection Range
Sep 06, 2022 - Sep 27, 2022
Pages
12
First Observation
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of inprocess material and the drug product.
Investigator(s): Robert J. Martin