* FDA releases report of inspection at Ameridose LLC
* Report details multiple sterility violations
* Says company improperly classified adverse events
By Toni Clarke
Nov 12 (Reuters) - U.S. health inspectors found bugs, a flying bird and other unsterile conditions at Ameridose LLC, an affiliate of the Massachusetts compounding pharmacy at the heart of the deadly meningitis outbreak.
Westborough, Massachusetts-based Ameridose was closed on Oct. 10 to allow state and federal investigators to inspect its facilities. On Monday the U.S. Food and Drug Administration released the results of its investigation.
The agency’s report details a list of quality control failures at Ameridose, including a failure to test the potency of its products, a failure to properly classify patient complaints and the use of “vague, canned language” when describing negative patient reactions to its drugs.
The company, an affiliate of the New England Compounding Center, said it is in the process of preparing a full response to the FDA.
“Ameridose’s history shows clearly that we have not had any instance of contaminated products over the course of the past six years, which covers the manufacture and shipment of 70 million units of product,” the company said in a statement. “Ameridose is committed to addressing all observations in order to enhance our existing systems.”
The investigation of Ameridose follows the closure of the NECC, which distributed thousands of vials of a steroid linked to an outbreak of fungal meningitis that has hit 19 states and claimed 32 lives.
Inspectors found that Ameridose failed to investigate customer complaints related to drug potency, under-filled products and syringe volumes. It also failed to classify “patient response” complaints as “adverse events.”
Several such complains referred to the drug oxytocin, used to induce labor in childbirth. One referred to “fetal distress and hyper stimulated uterus.” Another customer called to report an increase in post-partum hemorrhaging. Another reported that a patient had shortness of breath and that “the throat was closing.”
A complaint related to the painkiller fentanyl noted that the patient was “oversedated” and “unresponsive.” Another patient given the blood-thinner heparin experienced a “life-threatening” negative reaction.
Inspectors said buildings used to make, process, pack and hold the drugs were not maintained in a good state of repair. The firm failed to perform a microbiological assessment after “penetrating leaks” were found in a building and water dripping above the clean room.
“During the inspection we observed totes placed in the location of the penetrating leaks containing water,” the inspection report noted. “There is no documented evidence that the leaks were permanently corrected.”
Walls were cracked, corroded and covered with what appeared to be adhesive material in a room where sterile drugs are prepared, the report noted.
Equipment and utensils were not cleaned or sanitized at appropriate intervals to prevent contamination that could alter the safety, identity, quality or purity of the drugs, according to the report.
Certain metal surfaces “were observed to contain what appeared to be brownish structures, atypical in shape,” the report noted.
Moreover, the buildings used “are not free of infestation by rodents, birds, insects and other vermin,” the report said.
Specifically, insects were located in an area where finished sterile product is packaged and stored. The insects were also located within three to 10 feet of the controlled area where sterile products are manufactured.
At least one bird was observed flying in an area where sterile finished product is packaged and stored.
On Friday, Ameridose, which has the same owners as NECC, said it would lay off about 90 percent of its work force. About 650 employees at Ameridose will be affected, as well as 140 employees at Medical Sales Management, a company that provides sales, technology and human resources support to Ameridose.