FDA cites Nashville drug firm for 11 rule violations
Walter F. Roche Jr., wroche@tennessean.com; 7:36 p.m. CDT May 6, 2014
In the wake of increased state and federal vigilance following a nationwide meningitis outbreak, a Nashville producer of sterile drugs has been cited by federal authorities for multiple violations of regulations, including failure to perform tests and maintain sanitary conditions.
The five pages of violations were issued by the U.S. Food and Drug Administration following an inspection of the John W. Hollis Pharmacy earlier this year.
The FDA repeatedly cited the firm, located at 110 20th Ave. N., for failure to maintain adequate records.
“No data exists to assure sterility of these items through the time of their use, which is estimated to be a month,” the report states.
The inspectors also criticized employees of the pharmacy for reusing non-sterile gowns and failing to sanitize gloves after touching non-sterile surfaces.
“Clothing of personnel engaged in the manufacturing, processing and packing of drug products is not appropriate for the duties they perform,” said the report, which lists 11 violations.
The inspection began on Feb. 4 and ended on March 21 of this year.
Hollis issued a written statement in which he said only 13 vials of medication had been voluntarily recalled as a result of the inspection and that he had always sought to fully comply with state and federal regulations.
continue to read here
The five pages of violations were issued by the U.S. Food and Drug Administration following an inspection of the John W. Hollis Pharmacy earlier this year.
The FDA repeatedly cited the firm, located at 110 20th Ave. N., for failure to maintain adequate records.
“No data exists to assure sterility of these items through the time of their use, which is estimated to be a month,” the report states.
The inspectors also criticized employees of the pharmacy for reusing non-sterile gowns and failing to sanitize gloves after touching non-sterile surfaces.
“Clothing of personnel engaged in the manufacturing, processing and packing of drug products is not appropriate for the duties they perform,” said the report, which lists 11 violations.
The inspection began on Feb. 4 and ended on March 21 of this year.
Hollis issued a written statement in which he said only 13 vials of medication had been voluntarily recalled as a result of the inspection and that he had always sought to fully comply with state and federal regulations.
continue to read here
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