Caraco Pharmaceutical Laboratories, LTD. – FDA 483, Dec 22, 2008

The FDA Form 483 document details observations from an inspection of packaging facilities. A primary issue is the lack of pre-use inspection of packaging facilities to ensure removal of all drug products from previous operations. This deficiency has led to numerous instances, from May 2008 to the present, where inadequate cleaning procedures necessitated inspection of packaged finished product lots for foreign tablets. Examples include Meloxicam Tablet lot with Carvedilol 25 mg, multiple Metformin HCl Tablet lots with Mirtazapine 45 mg, Metoprolol Tartrate 50 mg, Metoprolol Tartrate 100 mg, and Atenolol Tablets 25 mg, and Zolpidem Tartrate Tablets with Carbamazepine Tablets 100 mg.

The responsibilities and procedures of the quality control unit are not fully followed, as evidenced by the lack of trending for Standard Operating Procedures (SPOs) issued in 2008. Reasons for SPO issuance include foreign tablets, thick/thin tablets (e.g., Clonazepam), and foreign contamination.

Batch production and control records are incomplete. For example, on December 11, 2008, a packaging problem with Zolpidem Tartrate Tablet lot, involving tablets spilling due to alignment issues, was observed but not documented in the packaging record. Furthermore, a review of the batch record for Zolpidem Tartrate Tablet lot 80311A showed no indication