The FDA, which issued India’s Laurus Synthesis a Form 483 in January, followed up the action with an "untitled letter" (PDF) that outlined the Indian drugmaker’s problems with its quality control unit and failures to properly clean equipment.
An "untitled letter" cites violations that do not meet the threshold of regulatory significance for a "warning letter," according to the U.S. regulatory agency.
In its latest action, the FDA slammed Laurus’ quality unit for failing to ensure critical deviations were investigated and resolved in the wake of the December inspection at its Anakapalli manufacturing facility located in Andhra Pradesh, India. That same inspection resulted in the agency issuing a Form 483.
The untitled letter said the facility’s quality unit didn’t thoroughly investigate an out-of-specification (OOS) result with one of its systems.
“You resampled your (redacted) water system and, after receiving a passing result, did not investigate the original OOS result or implement sampling process improvements to prevent future contamination,” the agency said in its letter.
Additionally, the agency cited Laurus for failing to adequately clean equipment and utensils, which could result in contamination that would alter the API being manufactured at the site.
Investigators said a preventative maintenance report from the company listed an unnamed piece of equipment “to be in a clean state" before the inspection. However, the agency found “apparent dirt and dark residue” on that same piece of equipment.
The FDA recommended Laurus hire a manufacturing consultant to perform a "comprehensive" audit of the company's "entire operation."
In the FDA's prior Form 483, Laurus was called out for not adequately conducting investigations of unexpected occurrences, inadequate sampling plans for intermediates, and not maintaining equipment in a way to prevent contamination.
Laurus was also cited in the Form 483 for keeping incomplete records related to batch production and controls.