FDA Blasts Laurus Synthesis With Untitled Letter
June 2nd, 2024 // 3:23 pm @ jmpickett
This month, FDA, which delivered an FDA 483 to India’s Laurus Synthesis in January, followed up that regulatory rebuke with an untitled letter that detailed the company’s problems with its QC unit and improper equipment cleaning. An untitled letter deals with violations that do not rise to the level of a warning letter, but should still be addressed.
In the latest regulatory action, FDA criticized Laurus’s QC unit for not ensuring that critical deviations were looked into and resolved after the December FDA inspection at the Anakapalli plant in Andhra Pradesh, India. That FDA inspection is what caused the agency to issue an FDA 483.
The untitled letter stated that the drug maker’s QC unit did not completely investigate OOS results with a particular system. The letter said that the company resampled its water system and after the system passed, did not do an investigation of the OOS result. Nor did it implement improvements to sampling processes to avoid contamination in the future.
Also, FDA said that Laurus did not completely clean utensils and equipment, which could lead to contamination that would change the API being made at the plant.
FDA auditors said preventive maintenance reports from the firm stated an unnamed piece of machinery to be clean before the audit. But the FDA found dark residue on that piece of machinery.
FDA stated that the company should retain a manufacturing consultant to do a complete audit of the plant’s entire operation.
In the January 483, Laurus was criticized for not doing investigations of unexpected occurrences. It also had improper sampling plans for intermediates, and did not correctly maintain equipment to stop contamination.
