FDA 483 - Precision Pharmacy Center, LLC - April 01, 2015

The FDA Form 483 documents significant deficiencies in the testing and control procedures for drug products. The facility fails to perform analytical testing for finished product potency prior to distribution for products such as Benzocaine/Lidocaine/Tetracaine PLO Gel (Lot 03192015@5), Progesterone SR 100 mg Capsules (Lot 03192015@9), Biestrogen SR 2.5 mg Capsules (Lot 03182015@12), and Testosterone SB 25% Cream (Lot 03182015@15).

Dissolution testing is not performed for modified release capsules, including Progesterone SR 100 mg Capsules (Lot 03192015@9) and Biestrogen SR 2.5 mg Capsules (Lot 03182015@12), to demonstrate appropriate active ingredient release. Non-sterile drug products, such as Lansoprazole 3mg/ml Syrup Suspension Solution (Lot 03232015@5) and Biest 1.875 mg/ml Sublingual Drops (Lot 03092015@15), are not tested for microbial contamination.

Control procedures are inadequate, lacking validation for manufacturing processes. Specifically, there is no data to support the adequacy of the blending