SigmaPharm Laboratories, LLC - Dec. 7, 2021
Issue Date
Dec 07, 2021
Region
Central
Category
Drug
$117.00
Contact Name
Sipridone S. Spireas
Contact Title
Chairman and CEO
Address 1
3375 Progress Dr.
City
Bensalem
State
PA
Zip/Postal Code
19020-5801
Country
United States
Inspection Range
Dec 01, 2021 - Dec 07, 2021
Pages
2
First Observation
Master production and control records lack complete manufacturing and control instructions and specifications.
Investigator(s): Marcellinus Dordunoo and Daniel J. Min