Medical Products Laboratories, Inc.

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 and follow appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile (21 CFR 211.113(a)).

Passage 2

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 3

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 4

Your firm failed to adequately investigate failing microbiological results in finished products. For example, your **(b)(4)** lot **(b)(4)** obtained a failing result of **(b)(4)** CFU/g for TYMC (specification ≤**(b)(4)** CFU/g). After your contract testing laboratory failed to identify the fungal species, you concluded, without evidence, that contamination occurred “during handling, transportation and/or testing.” You invalidated this failing result based on results of resampling and released the lot.

Passage 5

Your firm failed to conduct adequate investigations into OOS stability results. For example, in two separate incidents, you invalidated OOS stability results for subpotent assay without adequate scientific justification. You relied on resampling data from **(b)(4)**, lots **(b)(4)**, to invalidate the initial stability OOS result with no identified laboratory error or rationale.

Passage 6

Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).

Passage 7

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.