Laboratorios Dr. Collado S.A.

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 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 2

Your firm failed to demonstrate that you have appropriate testing procedures and specifications for asbestos testing conducted by your contract testing facility. Your firm uses a contract testing laboratory to test talc for asbestos using Scanning Electron Microscopy (SEM). Analytical SEM data that you submitted, showing magnification levels of only **(b)(4)**, was inadequate to determine the morphology of individual particles in the **(b)(4)** or to reliably detect and characterize potential asbestos fibers.