Fancystage Unipessoal, LDA

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 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 3

You failed to provide data to demonstrate you have adequately validated your manufacturing processes used to manufacture your OTC drug products and to demonstrate your processes are reproducible and controlled to consistently yield drugs of uniform character and quality. Additionally, you failed to provide data to demonstrate the qualification of your manufacturing equipment (e.g., **(b)(4)**, bottle filling, tube filling, etc.).

Passage 4

You failed to provide data regarding the validation of your **(b)(4)** system that is used as a component for your products and during equipment cleaning. Furthermore, you also failed to show that your **(b)(4)** system is adequately monitored to ensure it consistently produces **(b)(4)** that meets appropriate microbial limits.

Passage 5

Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).