Dr. Brite, 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 test samples of each component for identity and conformity with

Passage 2

You failed to adequately test each shipment of each lot of glycerin for identity, a component at higher risk for diethylene glycol (DEG) and ethylene glycol (EG) contamination. We note that glycerin is an ingredient used in some of your oral drug products, including those intended for infants and children. Records collected during the inspection show that your firm received at least one lot of glycerin from a region with confirmed or suspected contamination with high levels of DEG and EG.

Passage 3

Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Your firm also 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(a) and 211.165(b)).

Passage 4

Your firm failed to conduct adequate finished product release testing for each batch of your oral drug products and hand sanitizer drug products, including but not limited to, testing the identity and strength of active ingredients, and testing for objectionable microorganisms.

Passage 5

Your firm failed to establish an adequate quality unit (QU) with responsibilities to ensure adequate oversight for the manufacture of your drug products. For example, your QU failed to ensure:

Passage 6

Failure to register in accordance with section 510 of the FD&C Act and failure to provide listing information in accordance with 510(j) of the FD&C Act are prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p), and will render a drug misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(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.