FDA 483 - California Specialty Pharmacy Inc. - May 17, 2019

This FDA Form 483 document details observations from an inspection regarding the use of non-pharmaceutical grade components in drug product formulations. The firm used components not of pharmaceutical grade to produce various drug products.

Specifically, non-pharmaceutical grade (b)(4) water was purchased and utilized in the production of multiple nasal spray drug products. Examples include approximately (b)(4) lots of C-Ketamine Nasal Spray and (b)(4) lots of C-Oxycotin 24 units/mL Nasal Spray, both produced between February and May 2019. Additionally, approximately (b)(4) lot of C-Lidocaine HCl 4% Glycerin Nasal Spray was produced in April 2019 using this water. The firm has not submitted samples of this (b)(4) water to a contract laboratory for testing of microbial limits or other analytical properties to demonstrate equivalence to pharmaceutical grade water.

Furthermore, non-pharmaceutical grade Oxytocin was purchased and incorporated into non-sterile sublingual tablet and non-sterile nasal spray drug products. An example cited is approximately (b)(4) lots of C-Oxytoin Sublingual Tablets, produced between February and May 2019.