FDA Blasts Kilitch For Dirty Manufacturing Conditions
July 13th, 2024 // 1:13 pm @ jmpickett
It is usually understood that drug company workers have to wear gowns and be gloved when handling drug products and APIs in clean rooms. It also is necessary that the workers wear shoes.
However, Kilitch Healthcare India didn’t see things that way and failed to uphold such basic standards when FDA inspectors from the US visited their plant in Navi Mumbai at the end of 2024.
FDA blasted Kilitch in a four-observation FDA warning letter in April 2024. FDA stated in the warning letter that the company didn’t keep its manufacturing plant clean and that the facility was in a state of serious disrepair, dirty, and improperly maintained. FDA states that there was residue on HEPA filters, and cases where workers were using clearly dirty restricted access barrier products to adjust filling lines. There also were several barefoot employees who handled materials as they were transferred to a production room.
The FDA also criticized Kilitch for subpar practices related to written procedures related to microbial contamination. They also kept substandard laboratory records, which were issues that could cause QC and contamination issues.
FDA recommended in its warning letter that the company hire a production consultant to ensure that the firm meets FDA’s cGMP standards. Kilitch reported to FDA that it suspended drug production for items going to the US. However, FDA wanted to know if Kilitch wanted to resume sending drugs to the US in the future.
