# FDA WARNING_LETTER - Sage Products Inc - September 01, 2016

Source: https://www.globalkeysolutions.net/records/warning_letter/sage-products-inc/66c81951-848e-47e8-ba3a-21d84d62a0f6

> FDA WARNING_LETTER for Sage Products Inc on September 01, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Sage Products Inc
- Inspection Date: 2016-09-01
- Product Type: Drugs
- Office Name: Detroit District Office
- Summary: The FDA inspected Sage Products Inc.'s drug manufacturing facility from June 2 to September 1, 2016, revealing CGMP violations, rendering their drug products adulterated.

Key violations include:
1.  **Failure to validate test methods (21 CFR 211.165(e)):** Sage's (b)(4) microbiological screening method for liquid drug products was inadequate. It failed to reliably detect objectionable microorganisms like *Burkholderia cepacia*, leading to product recalls since 2006. The method's validation deficiencies include an insufficient dilution factor, lack of enrichment and scraping steps, and inadequate recovery of stressed organisms. The FDA advised using a verified compendial method.
2.  **Insufficient sampling plans and test procedures (21 CFR 211.160(b)):** Procedures for microbial enumeration were inadequate. A positive (b)(4) test result was not sufficiently investigated, with a small, unrepresentative sample used for "confirmatory" testing, potentially invalidating initial positive findings.
3.  **Failure to clean and maintain equipment (21 CFR 211.67(a)):** Bioburden analysis acceptance criteria for the Clean-in-Place (CIP) system failed to include *B. cepacia*, despite a history of contamination and a biofilm identified in the system.

Additionally, products manufactured by ChemRite CoPac, Inc. for

## Related Officers

- [Program Division Director](https://www.globalkeysolutions.net/people/art-o-czabaniuk/37f1e249-9ee6-4275-9c28-391d93659b85)
- [Brad Saar](https://www.globalkeysolutions.net/people/brad-saar/4dd6294c-ff1c-42f1-a2bb-3ebfb1c8c95c)

Company: https://www.globalkeysolutions.net/companies/sage-products-inc/c5c21659-188a-4f0e-b430-7bffff05c951

Office: https://www.globalkeysolutions.net/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03