BioAsia Worldwide Sdn Bhd

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 conduct at least one test to verify the identity of each component of a drug product. 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 21 CFR 211.84 (d)(2)).

Passage 2

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 (21 CFR 211.165(a)).

Passage 3

Your firm failed to perform appropriate testing on your drug products prior to release for distribution. For example, you rely on physical and organoleptic testing, such as appearance and odor. Furthermore, you failed to perform adequate testing on **(b)(4)** and **(b)(4)** to demonstrate appropriate strength for **(b)(4)** and **(b)(4)**, respectively, prior to release.

Passage 4

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 5

Your firm failed to validate your manufacturing processes for your OTC drug products. Your firm also failed to qualify equipment and validate your cleaning processes for non-dedicated equipment used to manufacture your OTC drug products.