OR WAIT null SECS
May 23, 2017
FDA cited the facility for violations of quality management and data integrity CGMPs.
May 11, 2017
FDA sent a warning letter to the company in India for delaying and limiting an FDA inspection in addition to problems related to cGMP.
May 09, 2017
FDA hopes to better use global resources and avoid duplicate inspections of foreign facilities.
FDA sent a warning letter to Pharmaceutic Labs, LLC for deficiencies in producing sterile drugs.
May 01, 2017
The agency has issued more than 90 warning letters over the past 10 years to companies selling fraudulent cancer treatments.
April 27, 2017
FDA sent a warning letter to Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd. after an inspection found the company failed to monitor and control quality.
April 12, 2017
The agency cited the company’s India facility for batch failures and data integrity problems.
April 02, 2017
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the value of internal audits and how the information gained can be applied.
March 28, 2017
The agency sent a warning letter to Opto-Pharm Pte Ltd. after deficiencies in sterile manufacturing procedures were found at the company’s Singapore facility.
March 21, 2017
FDA issued a warning letter to USV Private Limited citing CGMP violations that include data integrity and microbiological contamination issues.