CGMP ViolationsEvery API plant needs a pigeon feather or two.
Our investigator observed specific violations during the inspection, including, but not limited to, the following.
1. Failure to properly maintain, repair, and keep clean buildings used in the manufacture of APIs in a manner that prevents contamination where open equipment is used. For example,
a) Our investigator observed holes in the walls and roof which allowed pigeons access near production equipment in multiple manufacturing areas.
b) Gaps and holes in outside walls for piping and air ducts which allow contaminants to enter the building.
2. Failure to properly maintain equipment used in the manufacture of APIs and minimize the risk of contamination, where open equipment is used. For example,
a) Our investigator observed rust, dirt, lubrication leaks, and exposed insulation material on and around open drug manufacturing equipment.
We note that you continued to manufacture product intended for the U.S. market even after you recognized that your facility and equipment were in disrepair and not compliant with CGMP requirements. Your June 6, 2014, change control (CC14/001) stated, “Warehouse and Facility to be upgraded to achieve GMP standards.” However, in July 2014, you manufactured [redacted] API batches [redacted].
In your response, you state, “we have decided to divert the referred batches” to the domestic (India) market.
We acknowledge that you ceased manufacturing operations, on July 12, 2014, upon notice of FDA to inspect your facility. We also acknowledge that you have committed to complete various repair and renovation activities within 60 to 90 days, with the intention to assure a suitable facility. However, your facility was also under renovation during the previous FDA inspection in May 2011, when you made similar statements about ongoing renovations...
I love the factlet that the non-cGMP batches weren't a concern anymore since they've been sold to folks in India. Never mind!