FDA Warning Letter Reveals Major Gaps in Laboratory Testing, Component Controls, and Quality Oversight at Taiwanese OTC Manufacturer
FDA Warning Letter Reveals Major Gaps in Laboratory Testing, Component Controls, and Quality Oversi…
FDA Warning Letter Reveals Major Gaps in Laboratory Testing, Component Controls, and Quality Oversi…
A strong clinical package is not enough. This week’s inspection and audit news is a reminder that m…
TCI Co., Ltd BioCosme PABP BRANCH, based in Taiwan, received an FDA Warning Letter dated 2 Septembe…
**Company:** Bausch & Lomb Inc. **Country:** United States (Tampa, Florida facility) **Audi…
The World Health Organization has released a draft guidance on Quality Risk Management (QRM) design…
Global inspection activity is sending a consistent message. Authorities are still willing to accept…
ISO 9001:2015 Clause 6.1.1 – Actions to Address Risks and Opportunities: Consider Risks and Opportu…
Standard Operating Procedure (SOP) Clause 6.2 – Quality Objectives and Planning to Achieve Them ISO…
Clause 6 – Planning of ISO 9001:2015 ensures that the organization plans its Quality Management Sys…
Clause 5.3 - Leadership by Defined Roles & Responsibilities Standard Operating Procedure (SOP) …