FIRM IS CITED FOR WITHOLDING TRUTHFUL INFORMATION AND DELAYING AND LIMITING THE INSPECTION Wockhardt Ltd was recently audited by the FDA during the timeframe of March 18 – 22, 2013 at their Biotech Park, Aurangabad, India. During this audit the FDA documented that Wockhardt Ltd was found to have withheld truthful information, and delayed and limited the inspection. The delay … [Read more...]
FDA’s GUIDANCE FOR INDUSTRY PROVIDES CIRCUMSTANCES THAT CONSTITUTE DELAYING, DENYING, LIMITING OR REFUSING A DRUG INSPECTION
LEARN OF FDA's CURRENT THINKING REGARDING AUDITING ISSUES The FDA recently released a new DRAFT Guidance for Industry on July 12, 2013 that is entitled "Circumstances that Constitute Delaying, Denying, Limiting or Refusing a Drug Inspection". The Draft Guidance for Industry uses examples that illustrate the most common situations that the FDA has encountered and provides very … [Read more...]
