Genuine Virgin Aloe Corp dba Triderma

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. 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 2

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 3

Your firm failed to validate the processes used to manufacture your drug products. In addition, you could not provide evidence that you have qualified all of your manufacturing equipment.

Passage 4

Your firm failed to establish an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates. (21 CFR 211.166(a)).

Passage 5

Your firm failed to establish an adequate stability program and determine appropriate expiration dates for the drug products that you manufacture. You assigned a three-year expiry period to many of your drug products but failed to provide data to demonstrate that their chemical and physical attributes will remain acceptable throughout the expiry period assigned.

Passage 6

Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and (d)).