FDA 483 - Novel Laboratories, Inc. d.b.a Lupin Somerset - November 05, 2020

This FDA Form 483 document details observations from an inspection, primarily focusing on deficiencies in equipment cleaning, maintenance, and quality unit investigations.

**Facility and Operation Details:** The inspection covered various buildings and equipment used for manufacturing multiple drug products, including Tinidazole Tablets, Trimethoprim Tablets, Voriconazole Tablets, Hydrocodone Bitartrate/Homatropine Methylbromide Tablets, Phenelzine Sulfate Tablets, Methylergonovine Maleate Tablets, Temazepam Capsules, Trimethobenzamide HCl Capsules, Potassium Chloride Oral Solution, Hydrocodone/Acetaminophen Tablets, GaviLyte N (Lemon), and Flucytosine Capsules. Non-dedicated equipment is frequently utilized for different products.

**Violations and Observations:**

**Observation 1: Equipment and Utensils Cleaning and Maintenance Deficiencies** * **Contaminated "Cleaned" Equipment:** Numerous instances of equipment labeled "cleaned" were found with powder residue, visible damage, dirt, rust-like material, or water-like liquid. Examples include a blender (Equipment #0235) with unknown white powder and visible damage, a used drum without unique ID containing black mold-like appearance and powder residue, trays (Equipment #0351, #0352) with white powder residue, a capsule filling machine (Equipment #0247) with powder residue and rust-like material, a liquid processing equipment (Equipment #0837) with residual