American Peptide Company, Inc. - June 2, 2011
Issue Date
Jun 02, 2011
Region
Pacific
Category
Drug
$117.00
Address 1
1271 Avenida Chelsea
City
Vista
State
CA
Zip/Postal Code
92081-8315
Country
US
Inspection Range
May 16, 2011 - Jun 02, 2011
Pages
4
First Observation
Analytical methods used by the firm to test raw and in-process materials, finished intermediate API and stability samples are not validated for accuracy, robustness/ruggedness, range/linearity, specificity, limit of detection, and/or limit of quantitation as required by a written standard operating procedure.
Investigator(s): Virgilio F. Pacio and Kim L. Thomas