Pharmaceutics International, Inc. (Pii) announced that the U.S. Food and Drug Administration (FDA) has issued their Establishment Inspection Reports (EIRs) for both FEI registration numbers (1000513101/3006503102), covering Pii’s facilities in Hunt Valley and Cockeysville, MD.  The EIRs are related to General and Pre-Approval Inspections (PAIs) that occurred between October 23 and November 9, 2019, of non-sterile and sterile drug production facilities. Both EIRs indicate that Pii’s facilities are at “voluntary action indicated” or VAI status, which means the Agency found Pii to be in an acceptable state of compliance. Subsequent to the FDA’s inspection, and facility status recommendation, Pii has gained the FDA’s 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,” said Kurt Nielsen, president and chief executive officer, Pii. “Pii will continue to address observations noted during the inspection, and strive for the highest standard of product quality, compliance and customer service.”
 
Pii is a privately held contract development and manufacturing organization (CDMO) providing dosage form development and cGMP manufacturing services to the global pharmaceutical industry. Headquartered in Hunt Valley, MD, Pii’s services include pre-formulation development, and clinical and commercial cGMP manufacturing of parenterals, liquid solutions and oral solids, including soft gels, tablets and capsules. In addition, the company offers containment suites to handle potent drugs and Schedules I-V controlled substances.