FDA 483 - Sun Pharmaceutical Industries Ltd. - December 01, 2016

FDA investigators conducted an inspection of Sun Pharmaceutical Industries Ltd. in Halol, India, from November 28 to December 1, 2016. The inspection resulted in a Form 483 with four observations.

Observation 1 noted that the responsibilities and procedures applicable to the quality control unit were not fully followed. Specifically, the quality control unit failed to reject a batch of product that did not meet specifications. The firm released a batch of product (Batch A) that failed dissolution testing during stability studies. The firm initiated an investigation (IR-001) but concluded that the failure was an isolated incident and released the batch without further justification or retesting. This violates 21 CFR 211.22(a) and 21 CFR 211.192.

Observation 2 stated that laboratory controls did not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, and drug products conform to appropriate standards of identity, strength, quality, and purity. The firm's investigation into the dissolution failure of Batch A (IR-001) was inadequate as it did not identify a root cause and failed to implement effective corrective and preventive actions. This violates 21 CFR 211.160(b).

Observation 3 indicated that written procedures were not established for the