Bhargava Phytolab Private Limited

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to ensure that, for each batch of API, appropriate laboratory tests are conducted to determine conformance to specifications.

Passage 2

Failure to ensure that all specifications test procedures are scientifically sound and appropriate to ensure that your raw materials conform to established standards of quality and purity.

Passage 3

Your firm did not demonstrate that you adequately test incoming lots of **(b)(4)**, which is used to manufacture **(b)(4)**. For example, you relied on your vendor’s COA for **(b)(4)** testing that did not include potentially harmful impurities (e.g., **(b)(4)**).

Passage 4

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 5

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).