JW Nutritional 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 test samples of each component for conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(2)).

Passage 2

Your firm failed to ensure that components used in the manufacture of your over-the-counter (OTC) **(b)(4)** drug product “**(b)(4)**” are suitable for their intended use. You failed to perform adequate identity testing on each shipment of each lot of incoming components (e.g., **(b)(4)**).

Passage 3

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 4

You failed to validate your production and process controls.

Passage 5

Your firm failed to adequately qualify your **(b)(4)** system to ensure it produces **(b)(4)** that meets appropriate chemical and microbial attributes. You use **(b)(4)** as a component in your OTC drug product and to clean the manufacturing equipment.

Passage 6

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)).

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.