FDA 483 - Reed Pharmacy - September 27, 2018

This FDA Form 483 document details observations from an inspection, citing several violations related to drug product manufacturing and quality control. The facility produces drug products including LET (Lidocaine, Epinephrine, Tetracaine) topical solution, Eucerin / TMC 0.1% Cream 1:1 (Triamcinolone, Eucerin), and Canker Sore Rinse (Nystatin, Prednisone, Diphenhydramine, Tetracycline).

A primary observation is the lack of appropriate stability data to support expiration dates for drug products, specifically the LET topical solution, which is assigned a 6-month refrigerated shelf life without supporting studies. The firm has produced LET topical solution four times since February 2017.

Another critical finding is the use of food-grade Sodium Metabisulfite, lot #(b)(4), in LET topical solution without an expiration date or scientifically justified data to support its meeting release or stability requirements.

Furthermore, the firm does not perform laboratory testing for quality, strength, or purity of any drug products before release, despite producing and distributing multiple products since July 2018.

Finally, equipment and utensils, specifically product contact compounding surfaces, are cleaned with botanical cleaner and/or soap and water without scientific justification to ensure they are free from contamination, which could compromise the safety, identity, strength, quality, or purity of the drug products.