BioMylz Pvt. 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 adequate written procedures for production and process control designed to assure that 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 2

You failed to demonstrate adequate validation of your manufacturing process. You were unable to demonstrate that your **(b)(4)** processes assure **(b)(4)** after commercial scale-up of your process. For example, critical control process parameters such as **(b)(4)** were not adequately documented in batch records. Furthermore, you did not conduct adequate in-process hold time studies and stability studies to support shelf life.

Passage 3

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 4

You failed to ensure components and drug products are adequately monitored for microbiological contamination. For example, your topical psoriasis cream does not include testing for the presence of objectionable microorganisms, such as *Staphylococcus aureus* and *Pseudomonas aeruginosa*, critical for cutaneous products.