AnuMed International, 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 conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)).

Passage 2

You failed to perform adequate identity testing, including specific identity testing as appropriate, for each shipment of each lot of components, such as glycerin and ethyl alcohol (ethanol; alcohol), used in the manufacture of your drug products. During the inspection, you indicated that you were not aware testing was required and that you rely upon your supplier’s certificate of analysis (COA) for acceptance of incoming materials.

Passage 3

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 4

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

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)).

Passage 6

You failed to validate your non-compendial microbial methods used to test drug products and assure the methods were equivalent to or better than USP methods. For example, you use **(b)(4)** to analyze total count and yeast and mold in finished product. Additionally, you failed to follow the instructions for use and the investigator observed the use of expired **(b)(4)** test materials for finished product testing.