FDA Warning Letters – an understanding

As the primary regulator of the biological, healthcare, life sciences and other related industries; the FDA has power and authority over how its work is carried out. FDA Warning Letters are among the primary mediums through which it enforces its authority. The FDA issues a Warning Letter to a company when it determines, following its […]

Quality Assurance Auditing for FDA-regulated industries

An effective audit constitutes the heart of an effective Quality System. The FDA and other regulatory agencies have emphasized this principle time and again. The purpose of an audit program is to ensure proper and thorough compliance with the guidelines set out by the regulatory agencies. A Quality Assurance audit should also ensure that the […]