Friday, July 5, 2013
A report by federal health officials lists 25 observations of a Newbern pharmacy responsible for dispensing tainted medication to as many as 14 states this spring.
A document released by the Food and Drug Administration on June 11 lists practices observed over 10 inspection visits to Main Street Pharmacy in Newbern from May 22 until June 11. Although the report lists 25 official observations, many of the observations cited several examples of inappropriate practices observed during the inspections.
FDA investigators with the Department of Health and Human Services report findings ranging from clean room and sanitation violations to a lack of testing, record keeping and equipment maintenance. Observations also revealed lack of protective apparel and evidence of spiders in areas required to remain sterile.
Findings include:
* no validation of any procedure used in the processing of injectable drug products
* no logs maintained for equipment cleaning, maintenance or use of critical pieces of equipment
* the pharmacy does not use any type of sporicidal cleaning agent inside or outside of the ISO 6 cleanroom, which contains three ISO 5 hoods used in the processing of injectable drug products
* components brought into the clean room from an uncontrolled environment and placed on the work surface without being disinfected with sterile isopropyl alcohol
* product splatter on several surfaces in the clean room, charred black debris and stains on hot plate/stirrers, stained workbench surfaces, and a paper towel placed beneath a leaky motor to absorb the oil
* vials intended for use for injectable drug products stored open to the environment for multiple hours at a time when drug products were not being processed
* lack of protective apparel necessary to protect drug products from contamination including an employee wearing a surgeon's mask (which left exposed facial areas) and a non-sterile gown over street clothes while processing patient-specific injectable drug products labeled as sterile. The employee also had exposed legs, eye make-up and studded earrings at the time.
* the use of non-sterile wipes to clean workbench surfaces of the clean room
* the use of non-sterile gowns in the clean room
* buildings used in the manufacture, processing, packing or holding of a drug product not of suitable size, construction or location to facilitate cleaning, maintenance and proper operations including an ante room not large enough to allow for the proper gowning of employees prior to entering the clean room, no mirrors available to assure hair net coverage, no space provided for donning sterile gloves and a water faucet that is not hands-free
* the clean room floor composed of pieces of flooring joined by caulking, with caulking worn away to reveal a crack in the floor of the clean room
* the ceiling above the exterior of the clean room open to the uncontrolled room
* exposed insulation directly above the door leading into the ante room
* stains on the floor of the ante room near the trash can while the firm was processing
* the firm performs its own pest control, with no written pest-control procedures
* two spiders observed in the ISO clean room
* no hold times established and validated for drug products between processing steps
* no records exist to document hold times between filling finished product vials from bulk vials
* no written and approved procedures for the processing, packaging or storing of injectable drug products
continue reading here
A document released by the Food and Drug Administration on June 11 lists practices observed over 10 inspection visits to Main Street Pharmacy in Newbern from May 22 until June 11. Although the report lists 25 official observations, many of the observations cited several examples of inappropriate practices observed during the inspections.
FDA investigators with the Department of Health and Human Services report findings ranging from clean room and sanitation violations to a lack of testing, record keeping and equipment maintenance. Observations also revealed lack of protective apparel and evidence of spiders in areas required to remain sterile.
Findings include:
* no validation of any procedure used in the processing of injectable drug products
* no logs maintained for equipment cleaning, maintenance or use of critical pieces of equipment
* the pharmacy does not use any type of sporicidal cleaning agent inside or outside of the ISO 6 cleanroom, which contains three ISO 5 hoods used in the processing of injectable drug products
* components brought into the clean room from an uncontrolled environment and placed on the work surface without being disinfected with sterile isopropyl alcohol
* product splatter on several surfaces in the clean room, charred black debris and stains on hot plate/stirrers, stained workbench surfaces, and a paper towel placed beneath a leaky motor to absorb the oil
* vials intended for use for injectable drug products stored open to the environment for multiple hours at a time when drug products were not being processed
* lack of protective apparel necessary to protect drug products from contamination including an employee wearing a surgeon's mask (which left exposed facial areas) and a non-sterile gown over street clothes while processing patient-specific injectable drug products labeled as sterile. The employee also had exposed legs, eye make-up and studded earrings at the time.
* the use of non-sterile wipes to clean workbench surfaces of the clean room
* the use of non-sterile gowns in the clean room
* buildings used in the manufacture, processing, packing or holding of a drug product not of suitable size, construction or location to facilitate cleaning, maintenance and proper operations including an ante room not large enough to allow for the proper gowning of employees prior to entering the clean room, no mirrors available to assure hair net coverage, no space provided for donning sterile gloves and a water faucet that is not hands-free
* the clean room floor composed of pieces of flooring joined by caulking, with caulking worn away to reveal a crack in the floor of the clean room
* the ceiling above the exterior of the clean room open to the uncontrolled room
* exposed insulation directly above the door leading into the ante room
* stains on the floor of the ante room near the trash can while the firm was processing
* the firm performs its own pest control, with no written pest-control procedures
* two spiders observed in the ISO clean room
* no hold times established and validated for drug products between processing steps
* no records exist to document hold times between filling finished product vials from bulk vials
* no written and approved procedures for the processing, packaging or storing of injectable drug products
continue reading here
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