ALAMEDA, CA. – Today Emery Pharma has announced that on November 13th to 16th, 2018, FDA inspectors conducted a 4-day, unannounced, general inspection of our laboratory facility in Alameda, CA . The inspection included a tour of our entire facility and testing laboratories, then went into a representative review of our out of specification (OOS) investigations, change controls, analytical packets, and standard operational procedures. Additionally, an assessment of data integrity related to the various computer-based systems were conducted.
The inspection concluded on November 16th, closing out with no observations and no 483 findings. The following FDA report has determined that the inspection classification of Emery Pharma is “No Actions Indicated”. Based on this inspection, the inspectors considered our facility to be “in an acceptable state of compliance with regard to current good manufacturing practices (cGMP)”.
About Emery Pharma
“Helping Our Clients Save Lives and Save the Environment”
Located in Alameda, CA, the heart of the San Francisco Bay Area, Emery Pharma is an FDA registered, DEA licensed, and cGMP-GLP compliant full-service contract research and development laboratory. Combining the best intellectual resources with sophisticated instrumentation, the team specializes in analytical chemistry, microbiology, and cell biology services. Our mission is to support biotech and pharmaceutical companies aiming to save lives and save the environment.
The team at Emery Pharma has vast experience in method development and validation, characterization and isolation of impurities, stability studies, and release testing. We have proprietary and robust microbiological assays aimed to support projects related to novel antimicrobial, anti-biofilm, and antibiotic development. Our team also has extensive litigation support experience, including patent litigation, intellectual property, and product liability cases. Contact us and let us know how we can help advance your project.
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Contact us at: +1-510-899-8814 or 1-888-98-EMERY