Reliance Life Sciences 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

Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).

Passage 2

You failed to accurately document microbiology testing results. Specifically, multiple environmental monitoring and **(b)(4)** samples were documented in logbooks as collected and incubated; however, the corresponding plates could not be located in incubators during the inspection. Colony forming unit (cfus) counts had been recorded as if incubation was actively in progress. In interviews conducted by your management, your analysts confirmed these samples were not collected.

Passage 3

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 4

You failed to adequately clean, decontaminate, and maintain your **(b)(4)** used for aseptic drug product manufacturing. For example, our investigator observed multiple instances of deterioration and damage inside the **(b)(4)** used for manufacturing sterile drug products. These instances of deterioration and damage were not adequately addressed through your cleaning, decontamination, and maintenance programs. For example, our investigator observed: