Scientific Protein Laboratories, LLC
4 extracted findings
FDA source excerpt, selected passage
Failure to ensure that equipment surfaces in contact with raw materials, intermediates and API do not alter the quality of the intermediates and API beyond the official or other established specifications.
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 equipment surfaces in contact with raw materials, intermediates and API do not alter the quality of the intermediates and API beyond the official or other established specifications.
Source passage selected by the model
02
Failure to establish and follow written procedures for investigating critical deviations or the failure of intermediates and API lots to meet specifications.
Source passage selected by the model
03
You failed to conduct adequate investigations into out-of-specification (OOS) results. For example:
Source passage selected by the model
04
Failure to address deviations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any deviations.
Source passage selected by the model