IDO Pharm Co., Ltd.

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 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 2

Your firm did not establish procedures describing the operation, cleaning, maintenance, or validation of your **(b)(4)** system, which is used to make a component of your drug products. Hoses were observed to contain stagnant **(b)(4)**, and your **(b)(4)** tank contained visible particulate matter floating on the **(b)(4)** surface, including what appeared to be an insect.

Passage 3

Your firm did not conduct process validation or equipment cleaning validation for your **(b)(4)** over-the-counter drug products.

Passage 4

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 5

You failed to appropriately establish and validate your gas chromatographic (GC) method for assay testing of **(b)(4)** in your finished drug products. Also, you failed to validate your GC method for determining **(b)(4)** and volatile impurities in your **(b)(4)** raw material. In addition, you failed to test your **(b)(4)** raw material for the presence of **(b)(4)** and volatile impurities.