Piramal Pharma's Lexington Facility Gets Six Observations From U.S. FDA
The inspection was conducted from Dec. 27 through Jan. 10 by the U.S. regulator.
The U.S. drug regulator, following a pre-approved inspection, issued Form 483 with six observations to Piramal Pharma Ltd.'s Lexington facility in Kentucky, U.S.
The company said that the facility was inspected by the U.S. Food and Drug Administration from Dec. 27, 2022, through Jan. 10, 2023, according to its exchange filing.
"At the conclusion of the inspection, the U.S. FDA issued a Form 483 with six observations," it said. "The observations were classified under VAI (Voluntary Action Indicated) and do not relate to data integrity."
Voluntary action indicated means that the U.S. FDA has found objectionable conditions at the facility during an inspection, but the agency will not take or recommend any administrative or regulatory action because the objectionable conditions do not meet the threshold for action at this time.
Despite this facility inspection classification, FDA recommends that the observations noted on Form 483 be addressed at the conclusion of the inspection. If not corrected, the same or similar conditions could lead to a future inspection being classified as 'official action indicated'.
Accordingly, the company said that it "is preparing a detailed response to the observations, which will be submitted to the U.S. FDA within the stipulated timelines."
An inspection classification of VAI does not directly impact negatively the FDA’s assessment of any pending marketing application referencing this facility. Thus, there may not be any material impact on the product approval from the facility.