FDA Warns Coram for Sterile Drug Deficiencies
The FDA issued a warning letter to Coram Healthcare over its Crownpoint, Ind., facility for serious deficiencies in producing sterile drug products.
A Dec. 1, to Dec. 16, 2014, inspection resulted in a Form 483 after inspectors found that drug products were prepared, packed or held under insanitary conditions, according to the Aug. 11, 2015, warning letter.
For example, an operator was observed resting gloved hands on the workbench surface of the ISO 5 laminar flow hood and the gloves were not always appropriately sanitized. The facility also did not perform adequate cleaning and disinfection of the work surfaces, supplies and equipment within the aseptic processing area.
Moreover, the firm failed to show that its laminar flow hood is able to provide adequate protection of the drug production area.
The FDA also dinged Coram for failing to provide documentation or sufficient detail of corrective actions.
Coram said it is working with the FDA to ensure compliance. Read the warning letter here: www.fdanews.com/09-16-15-coram.pdf. — Michael Cipriano