Shimoga Chemicals
5 extracted findings
FDA source excerpt, selected passage
Failure to ensure that all specifications, sampling plans, test procedures are scientifically sound and appropriate to ensure that your API conform to established standards of quality and purity.
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
01
Failure to ensure that all specifications, sampling plans, test procedures are scientifically sound and appropriate to ensure that your API conform to established standards of quality and purity.
Source passage selected by the model
02
Your firm did not perform verification studies for any test methods, including but not limited to identification, related substances by HPLC, residual solvent, and assay by HPLC for clomiphene citrate USP. For example, your firm failed to verify the residual solvent method used by your contract testing laboratory. Additionally, during the inspection, your QC manager confirmed that no method verification has been performed for any of the test methods used for clomiphene citrate USP.
Source passage selected by the model
03
Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes.
Source passage selected by the model
04
Your firm failed to establish adequate process validation for clomiphene citrate USP and its key starting materials. Your process validation reports do not accurately reflect actual manufacturing practices. For example, your validation reports fail to address the **(b)(4)** operation. Also, your validations do not address routine hold times. For example, **(b)(4)** batch **(b)(4)** was stored for approximately **(b)(4)** without defined hold-time limits or supporting studies.
Source passage selected by the model
05
Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP.
Source passage selected by the model