Drug factory · FDA FEI 3008252295

Rubicon Research Limited

Plot No K-30/4 & K30/5, MIDC, Additional Ambernath Area, , Thane, India

What it does, for whom

FDA inspection history

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Jan 27, 2023 inspection

• In-process materials characteristics testing 21 CFR 211.110(c)
  In-process materials are not tested for identity, strength, quality and purity and approved or rejected by the quality control unit during the production process and after storage for long periods.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

Registered with FDA for: analysis; label; manufacture; pack.