FDA 483 - Sandoz Incorporated - May 06, 2011

This FDA Form 483, issued on May 6, 2011, to Sandoz Incorporated, a drug manufacturer located at 2535 West Midway Boulevard, Broomfield, CO 80020-1632, details eleven observations made during an inspection from April 19, 2011, to May 6, 2011.

**Key Observations:**

1. **Lack of Process Validation:** Control procedures are not established to validate manufacturing processes causing variability. Specifically, blenders used interchangeably for Triamterene and Hydrochlorothiazide (50/25) Capsules between 1998-2007 lacked process validation for one of the blenders, which had a different configuration. This was linked to a downward trend in finished product dissolution. 2. **Inadequate Investigation of Discrepancies:** Investigations of unexplained discrepancies did not extend to other batches or products, and corrective actions were not established. This was observed in 14 out of 79 (18%) laboratory investigations, including blend uniformity failures and out-of-specification API identity and finished product related compound results that were re-run without root cause analysis. 3. **Laboratory Water Contamination (Repeat Observation):** Purified laboratory water repeatedly failed microbiology specifications due to biological contamination from stagnation in a non-circulating branch. While the firm stated it doesn'