Midlab Incorporated

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 conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(b)).

Passage 2

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 3

You failed to investigate out-of-specification (OOS) assay results during stability checks for several batches of your antibacterial hand soap drug products. For example, assay testing for chloroxylenol in your antibacterial hand soap drug product revealed results including 0.31% at the **(b)(4)** timepoint stability check. Your specification for this product attribute was **(b)(4)**%. You failed to conduct any investigation into the OOS result.

Passage 4

Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

Passage 5

Failure to address violations 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 violations 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 violations.