Grupo Quimico SRL

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).

Passage 2

Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).

Passage 3

Your firm did not have adequate procedures governing the collection, review, and integration of data generated through electronic systems. For example, your procedures did not require evaluation of electronic data which included reprocessed sample integration, aborted runs, single injection data, and electronic audit trails (when available). Accordingly, your QU failed to review this data. Further, manual integration is performed without a governing procedure.

Passage 4

Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).

Passage 5

Your firm did not have appropriate controls over your analytical equipment and software to prevent deletion of data and record all modifications to data. Specifically, electronic data generated by your HPLC software recording the testing of drug products, could be deleted by your analysts. Additionally, your HPLC systems “HPLC 03” and “HPLC 04” did not have audit trails enabled.