Cadila Healthcare Hit With 483 After Rare International FDA Inspection
April 6th, 2022 // 3:43 pm @ jmpickett
After a 10-day FDA inspection in late Feb and early March 2022, FDA sent a 483 with several serious observations to Cadila Healthcare and its sterile injectable manufacturing facility in Jarod, India.
FDA noted in the inspection documents that the facility mostly makes injectable drugs for the American market. But FDA noted that not only were there doubts about the site’s quality and state of repair, the QC unit didn’t test more than 250 stability samples in the mandatory number of days as noted in the firm’s SOP.
Several sterility tests were delayed more than four months, FDA noted. The QC unit also did not do the required yearly product quality reviews for several products, but the 483 didn’t say which injectables were involved.
Cadila, also known as Zydus Lifesciences, earlier disclosed that the injectables it produces at the plant include glycopyrrolate, doxycycline to treat various infections, and haloperidol decanoate, which is used to treat schizophrenia.
The condition of some parts of the facility were also subpar, FDA noted, with the compounding room for making sterile injectable drugs in poor condition, which could lead to product contamination.
For example, the agency found that layers of paint had come off the ceiling and fell into a HEPA filter that was positioned above the compounding room. The FDAer said sealant around the pipes where they go through the facility ceiling were rough, so the surface was hard to clean.
The release of this international FDA inspection document is notable because there have rarely been any during the COVID pandemic. From April to September 201, FDA said it only did 37 foreign audits. That compares to almost 2000 in 2019 alone. ;
How the agency prioritizes cgmp inspections now that the pandemic is somewhat abating will indicate to industry what FDA is most concerned about.
Cadila’s FDA 483 is one of several agency warnings for the firm’s plants based in India. Another site in Moraiya, India got a warning letter three years ago when FDA found major equipment flaws and cleaning problems that caused cross-contamination between drug products.
