Sun says Halol plant cited again by the FDA

Halol manufacturing facility
Sun Pharmaceutical's Halol plant has a history of regulatory concerns that include repeated Form 483s, warning letters and complete response letters for drugs for which it was seeking approval. (Sun Pharma)

After years of criticism from the FDA, Sun’s Halol plant still can’t get through an FDA inspection without the agency finding some deficiency. In June, it was just one observation, but a just completed inspection ended with a Form 483 for Halol with significantly more.  

The Indian drugmaker reported (PDF) over the weekend that an inspection from Dec. 3 through Dec. 13 had resulted in the FDA citing the key facility with eight observations. It didn’t say what issues were uncovered but insisted it was committed to working with the FDA to fix these problems as well as to improve its manufacturing systemwide. 

RELATED: Sun wins approval of glaucoma drug and its once-troubled Halol plant to produce it

Sun has spent years trying to convince the FDA that its manufacturing at Halol is meeting agency standards. The setbacks, first laid out in a Form 483 in 2014 and followed by a warning letter in 2015, have kept it from winning some new drug approvals from the facility, hurting Sun’s growth.

The warning letter even led the FDA in 2015 to revoke approval of a new epilepsy drug developed by biotech SPARC for Sun. The FDA issued a second complete response letter for the treatment in 2017, again citing the plant problems.

Last year, however, the drugmaker got the green light from the agency to manufacture a SPARC treatment for glaucoma at Halol, indicating the plant had won enough good will to get drug approvals.