FDA 483 - Town Total Compounding Center - April 20, 2016

The FDA Form 483 inspection revealed multiple deficiencies at the facility related to drug product stability, aseptic processing, and environmental monitoring.

**Stability Program and Expiry Dates:** * No written testing program for drug product stability. * No written stability program for sterile compounded sterile preparations (CSPs) to support assigned expiration dates. * Failure to follow the written SOP "Assignment of Beyond-Use Date for Sterile Compounded Preparations" when assigning expiry dates. * Preservative-free products lacking adequate stability data and sterility tests were assigned beyond-use dates exceeding written procedure requirements. * Examples of specific products with extended expiry dates include Glycerin 100% (Lot 44462015, 180 days), Glycerin 72% (Lot 03252016@10, 90 days), Glycerin 72%/Lido1%-Epi 1:100000 (90 days), Pilocarpine HCl 2% Oph Soln (28 days), Ceftriaxone Nasal 2.5ml (90 days), and Trimix #4 (90 days). * Glycerin 100% Lot 44462015 was sterilized below the required sterilization. * Products with preservatives, lacking stability and sterility data, were assigned expiry dates