Cipla Limited

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 thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Passage 2

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)).

Passage 3

You failed to appropriately evaluate a pattern of media fill failures in your facility and afford sufficient attention to potential correlations among these contamination events. Between February 2021 and March 2022, there were multiple aborted and contaminated media fills on **(b)(4)** filling lines **(b)(4)** and **(b)(4)** (solution and suspension lines). For example,

Passage 4

You failed to appropriately investigate root causes and implement effective CAPAs to prevent recurrence of contamination events. For example, you failed to substantively evaluate the personnel and environmental monitoring (EM) data obtained during the production of these media fill batches, and to comprehensively assess additional historical data from the manufacturing area.

Passage 5

You failed to provide adequate justification for the discontinuation of filling **(b)(4)** surface monitoring on your **(b)(4)** lines. For example, prior to January 2020, your EM plan required collection of surface samples from **(b)(4)** filling **(b)(4)** at the **(b)(4)** of filling of **(b)(4)** batch. However, from January 2020 to August 2022, you did not collect surface samples from the **(b)(4)** filling **(b)(4)** at the **(b)(4)** of filling of **(b)(4)** batch.

Passage 6

Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures (21 CFR 211.22(d)).