OR WAIT null SECS
February 15, 2017
The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.
The company has voluntarily recalled all lots of of human chorionic gonadotropin because of a lack of sterility assurance.
February 02, 2017
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses how to ensure sterility when manufacturing small-scale parenteral batches.
January 25, 2017
The agency finds repeated CGMP violations at Porton Biopharma, Limited.
The company issues a voluntary nationwide recall due to the presence of particulate matter in a single vial.
January 09, 2017
The company was cited by FDA for violations of sterile processing GMPs.
December 02, 2016
Airlocks, gowning rooms, and transition spaces have different uses and should be considered separately in cGMP pharmaceutical facility design.
November 28, 2016
Wockhardt Limited received a warning letter from FDA for CGMP violations.
October 02, 2016
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.
This key bioprocessing segment is expecting continued growth