Dunagin Pharmaceuticals Inc. dba Massco Dental

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 have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups (21 CFR 211.42(c)).

Passage 2

Your firm failed to test samples of each component for conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(2)).

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 provide data to demonstrate you have validated the manufacturing processes for all your drug products. During the inspection, when asked for validation documents for your manufacturing processes, you stated that you did not have any validation information.

Passage 5

You failed to adequately maintain equipment used in the manufacture of your drug products. For example, motorized mixing equipment located in your liquid manufacturing area was observed in a poor state of repair, with rust and paint chipping.

Passage 6

Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).

Passage 7

You failed to provide adequate oversight of finished product testing, and other quality functions. For example, your Quality Unit (QU) failed to initiate and document an investigation into out-of-specification (OOS) results. During the inspection, our investigator observed your analyst obtained OOS finished drug product assay results. You stated the results would be discarded, and the tests would be reperformed by a different analyst.

Passage 8

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 9

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.