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FDA clears Piiís Maryland sites
June 2019
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HUNT VALLEY, Md.—Pharmaceutics International Inc. (Pii) recently received Establishment Inspection Reports (EIRs) for its Hunt Valley and Cockeysville, Md. locations from the FDA. The EIRs are related to General and Pre-Approval Inspections conducted between Oct. 23 and Nov. 9, 2018, of the company’s non-sterile and sterile drug production facilities. Both facilities were deemed “voluntary action indicated,” or in an acceptable state of compliance. With this, Pii has received FDA approval of four sterile and non-sterile products.
 
“The successful completion of the FDA facility inspection is a very positive development for Pii, as we continue on our journey to meet and exceed U.S. and international regulatory requirements. Pii will continue to address observations noted during the inspection, and strive for the highest standard of product quality, compliance and customer service,” said Dr. Kurt Nielsen, Pii’s president and CEO.

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