OR WAIT null SECS
February 02, 2017
The warning letter cited GMP violations for finished drug products.
February 01, 2017
FDA issued a warning letter to Cixi Zhixin Bird Clean-Care Product Co., Ltd for violations of cGMP for finished pharmaceuticals.
Pharmco Laboratories received an FDA warning letter for significant violations of CGMP for finished drugs and APIs at its Florida, US facility as well as misbranding of over-the-counter (OTC) acne and sunscreen drug products.
January 25, 2017
The agency finds repeated CGMP violations at Porton Biopharma, Limited.
FDA’s Office of Regional Affairs aims to implement Program Alignment initiative by May 15, 2017.
January 20, 2017
FDA cites Sato Yakuhin Kogyo Co., Ltd. with data integrity violations after a June 2016 inspection of its Kashihara City facility.
January 09, 2017
The company was cited by FDA for violations of sterile processing GMPs.
January 02, 2017
Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to handle audits and inspections during business expansion.
December 20, 2016
The agency put Baoying County Fukang Medical Appliance Co., Ltd. on import alert after observing violations at the company’s Yangzhou City facility.
December 07, 2016
FDA issued a warning letter to Interquim, SA for CGMP deviations at its Barcelona API facility.