Laboratorio Magnachem International

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 thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

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

You failed to adequately establish microbiological test methods for objectionable microorganisms, microbial counts, and detection of *Burkholderia cepacia* complex (BCC). Your quality unit confirmed that you have not performed adequate method validation and United States Pharmacopeia (USP) method verification to ensure your microbial test methods accuracy and reliability.

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)).