Avlon Industries, Inc.

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 211.84(d)(2)).

Passage 2

Your firm failed to test your incoming components for identity prior to manufacturing your over-the-counter (OTC) drug products (e.g., active ingredients, glycerin, and water as a component). Additionally, you relied on certificates of analysis (COAs) from unqualified suppliers for specifications such as purity, strength, and quality. By not adequately analyzing your components for identity, purity, strength, and quality, you failed to ensure your incoming components meet appropriate specifications.

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, and to follow all of your written production and process control procedures. (21 CFR 211.100(a) and 211.100(b)).

Passage 4

You failed to provide data to demonstrate that you adequately validate your manufacturing processes used to manufacture your OTC drug products and demonstrate that your processes are reproducible and controlled to consistently yield drugs of uniform character and quality.

Passage 5

You failed to provide evidence that you performed cleaning validation for the equipment (e.g., mixing tanks, hoses, filling lines, and packaging lines) used to manufacture your OTC drug products. This is a repeat observation from the 2017 FDA inspection. Additionally, you lacked cleaning and usage logs for production tanks (i.e., kettles), or any holding tanks used in manufacturing your bulk drug products.

Passage 6

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.