# FDA 483 - Sandoz Incorporated - May 06, 2011

Source: https://www.keypedia.com/records/483/sandoz-incorporated/baaabca0-2926-45dd-a2f6-0907f5119191

> FDA 483 for Sandoz Incorporated on May 06, 2011. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sandoz Incorporated
- Inspection Date: 2011-05-06
- Product Type: Drugs
- Office Name: Denver District Office
- Summary: 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'

## Related Documents

- [483 - 2019-04-16](https://www.keypedia.com/records/483/sandoz-incorporated/afbe4c62-da17-4bdc-a1ca-e2ca1b463f6f)

## Related Officers

- [Compliance Officer / Investigator](https://www.keypedia.com/people/erika-v-butler/3e654530-4c29-403d-880e-a5422315c3c0)
- [Supervisory microbiologist](https://www.keypedia.com/people/zachery-l-miller/e7ff2001-1e81-4483-9e9b-288b7e92c719)
- [Consumer Safety Officer  ](https://www.keypedia.com/people/kimberley-a-hoefen/eb3bc154-a71e-4cc7-af25-9a6f0810d239)

Company: https://www.keypedia.com/companies/sandoz-incorporated/6aa8ae0e-b0f0-49a7-a584-c6e6796c6481

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face