U.S. FDA Flags Five Lapses At Cipla Subsidiary's New York Facility
The inspection was conducted from Sept. 11 to Sept. 19. There was no repeat or data integrity observation, the company said.
The U.S. drug regulator has flagged five lapses at Cipla Ltd.'s fully owned subsidiary's manufacturing facility in New York.
"An inspection was conducted by the United States Food and Drug Administration at the manufacturing facility of InvaGen Pharmaceuticals Inc., the wholly owned subsidiary of the company located in Central Islip, Long Island, New York, USA, from Sept. 11 to Sept. 19," the company said in an exchange filing on Sept. 20.
The inspection was a routine current good manufacturing practices inspection and a pre-approval inspection for a site transfer product within InvaGen, the filing said.
On the conclusion of the inspection, InvaGen had received five inspectional observations in Form 483.
A Form 483 is issued when investigators have observed any condition that, in their judgement, may constitute a violation of the Food, Drug, and Cosmetic Act and Related Acts.
The company had disclosed that there were no repeat or data integrity observations and that it will work closely with the U.S. FDA and is committed to addressing these comprehensively within the stipulated time.
BQ Prime has obtained a copy of the observations from the administrator.
These are the observations that were made:
Written procedures were not reviewed and approved by the quality control unit, specifically the continued use of good manufacturing practice documents that were drafted and approved prior to Cipla purchasing the facility in 2018.
In-process materials are not tested for and approved or rejected by the quality control unit during production and after storage for long periods. Within the review period of a year and a half, eight instances of the manufacturing time exceeding the time limits were noted, and no scientifically sound written justification was provided for not putting these batches on stability.
Labelling and packaging materials are not sampled and tested before use in packaging and labelling a drug product. The firm does not count and verify the number of printed drug labels present in a roll of labels received from the vendor.
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination of drug product. Instances of the presence of unknown white material were noted on the cleaned and ready-to-use sieve screen and tablet dies during the walkthrough.
Responsibilities and procedures applicable to the quality control unit are not fully in writing and fully followed. There is no due date required for the completion of change controls, and numerous change controls initiated continue to remain open.
Emailed queries regarding the impact of the observations on revenues and the time period of resolution sent to the company remain unanswered at the time of publication.
Shares of Cipla closed 0.51% lower at Rs 1161.10 apiece, as compared with a 0.62% rise in the benchmark Sensex on Thursday, Oct. 5.
