Jamol 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 laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components conform to appropriate standards of identity, strength, quality, and purity, and conduct for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.160(b) and 211.165(b)).

Passage 2

You failed to establish an identification test with adequate specificity to appropriately test incoming lots of Eucalyptus Oil to meet the United States Pharmacopoeia (USP) monograph. Specifically, your test procedure fails to include an appropriate test using infrared spectroscopy for identification.

Passage 3

Your firm failed to establish 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 4

You failed to adequately validate the processes used to manufacture Ponaris, and do not have an ongoing program for monitoring process control, to ensure stable manufacturing operations and consistent drug quality.

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.