FDA Discovers Violations and Contaminated Drugs at Compounding Pharmacies
EMSL Analytical provides sterility and USP Monograph testing in our FDA registered and DEA licensed laboratory.
According to the Los Angeles Times, inspectors from the U.S. Food and Drug Administration (FDA), have recently discovered major violations at drug compounding pharmacies, including mold and rust in rooms where injectable drugs are packaged, black particles floating in medication, and workers handling sterile products with bare hands.
Investigations were conducted at 31 drug compounding pharmacies across 18 states in response to last year’s fungal meningitis outbreak from tainted drugs that caused 733 illnesses and 53 deaths. All but one of the 31 pharmacies were issued inspection reports or FDA Form 483, reports typically issued before the FDA takes formal action.Four of the pharmacies initially refused full access to records or their facilities, and in two cases the FDA had to obtain search warrants and return with U.S. Marshals in order to complete their inspections.
Compounding pharmacies are licensed to prepare customized drugs for individuals based on doctor’s prescriptions. However, many pharmacies have begun supplying hospitals and clinics with bulk quantities of drugs without prescriptions.
“It is critical that compounding pharmacies perform Sterility and USP Monograph on their products and active pharmaceutical ingredients periodically to protect consumers from potentially dangerous contaminations,” states Diane Miskowski, MPH, Business Development Manager at EMSL Analytical, Inc. “To assist compounding pharmacies in complying with USP 797 standards, EMSL Analytical, the nation’s leading environmental testing laboratory, provides sterility testing for controlled substances in our FDA registered, DEA licensed laboratories.”
About EMSL Analytical, Inc.
EMSL Analytical is a full service testing company providing quality lab services under the same private ownership since 1981. Including the corporate lab facility in Cinnaminson, NJ, EMSL Analytical operates over thirty laboratories nationwide in the US and Canada. We provide analytical services for environmental, indoor air quality (IAQ), industrial hygiene, forensics and materials science, consumer products, food safety, PCR, pharmaceutical, asbestos, lead, and radiological samples. The company has an extensive list of accreditations from leading organizations, as well as state and federal regulating bodies.
- Contact Information
- Joseph Frasca
- Senior Vice President of Marketing
- EMSL Analytical
- (1) 1-800-220-3675
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