Nature’s Fusions 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 establish a written testing program designed to assess the stability characteristics of drug products and determine appropriate storage conditions and expiration dates. Your firm also failed to have buildings used in the manufacture, processing, packing, or holding of drug products with adequate space for the orderly placement of equipment and materials to prevent mix-ups and contamination (21 CFR 211.166(a) and 21 CFR 211.42(b)).

Passage 2

Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Passage 3

You failed to test all incoming raw materials, including isopropyl alcohol received from suppliers, used to manufacture your OTC hand sanitizer drug product. You relied on your supplier’s certificate of analysis (COA) for components, such as isopropyl alcohol, in lieu of testing each component for purity, strength, identity, and quality.

Passage 4

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 5

You failed to conduct adequate finished product release testing for each batch of your drug product, including but not limited to, testing the identity and strength of the active ingredient, isopropyl alcohol and testing for objectionable microorganisms. For example, your COA for **(b)(4)** indicates that you calculated the assay value instead of performing testing, and that you only performed organoleptic evaluation for appearance, color, and odor.

Passage 6

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 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.