Maison Terre, LLC

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

Passage 2

Your firm failed to test before use each lot of a component, drug product container, or closure with potential for microbiological contamination that is objectionable in view of its intended use (21 CFR 211.84(d)(6)).

Passage 3

Your firm failed to establish a 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 4

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 5

Failure to promptly address these deviations and violations may result in legal action without further notice including, without limitation, seizure and injunction. Other Federal agencies may take your compliance history into account when awarding contracts.

Passage 6

Failure to address violations of FD&C Act sections may be cause for FDA to withhold issuance of Export Certificates and may be cause for FDA to withhold approval of new applications or supplements listing your firm as a drug manufacturer. We may conduct a follow-up inspection to verify that you have completed your corrective actions.