FDA 483 - Cincinnati Specialty Pharmacy, L.L.C. - September 26, 2016

This FDA Form 483 was issued to Roger G. Hospelhorn, Owner/President of Cincinnati Specialty Pharmacy, LLC., located at 7731 Cox Lane, West Chester, OH 45069. The inspection, conducted by Nicholas L. Palumbo and Mary Loh, occurred on various dates between September 6 and September 26, 2016. The establishment is identified as a producer of Non-Sterile Drug Products.

The primary observation, citing 501C of the FD&C Act, indicates that the firm released drug products where the strength, purity, or quality differed from what was represented. Specifically:

1. **Potency Issues in Finished Drug Products:** * Two finished drug products, T4 (Levothyroxine) 50mcg/T3 (Liothyronine) 25mcg capsules (Lot 07-14-2016@9) and T4 (Levothyroxine) 110mcg/T3 (Liothyronine) 16mcg capsules (Lot 07-20-2016@36), were released to patients with Liothyronine (T3) potency 10 times less than prescribed. This was attributed to insufficient T3 (b)(4) being added during production. * Pharmacists reviewed and approved these production records