Aruba Aloe Balm N.V.

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 all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Passage 2

You failed to ensure that incoming lots of active pharmaceutical ingredient (API) were suitable for use in manufacturing your over-the-counter (OTC) drug products intended for the U.S. market.

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

Passage 4

Your firm failed to adequately test your OTC drug products for identity and strength of active ingredients prior to release and distribution into the U.S. market. Also, you lacked adequate microbiological testing for each batch of your OTC drug products prior to release. For example, you released your Alcoholada Gel drug product based on testing pH, viscosity, weight, and appearance.

Passage 5

Your firm failed to establish adequate 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 6

Your firm failed to adequately validate your production and process controls. As such, you do not have assurance that you are capable of consistently manufacturing OTC drug products with defined quality attributes.