A Bit About Us
We are a small family-owned and operated manufacturing and distribution company specializing in offering high-end skin care and hair care products as well as topical over-the-counter drugs to other business of any size. The low end of our manufacturing capacity is often under 1000 units and sometimes less than 500 units of special items. The high end of our capacity reaches up to 3.6 million units per month of some products. We can fill almost any type of package in sizes ranging from 1.0 ml. to 200 gal.
Privately Owned & Operated
Paula Wedegartner
President
William Thomas Loesch III
Vice-President
William Thomas Loesch, Jr., Ph. D.
Executive Secretary
FDA Registered & Inspected
Regulatory Compliance is one of the highest priorities at our company. All of our equipment cleaning, materials handling, data storage, and validation research is used to guarantee compliance with an array of government agencies. The most prominent are the FDA (Food & Drug Administration) and the TDH (Texas Department of Health) which provide regulations which prevent cross-contamination and misbranding* of products. Our personnel will review your labeling and other printed materials to ensure that wording, claims, and artwork complies with the necessary regulations. A "Continuing Guarantee" is a document issued by the manufacturer of a product to its buyers guaranteeing that all regulations are being followed.
Equipment Validation proves that machinery is made of the right materials, tubing is compatible with the products flowing through them, thermostats maintain proper temperatures, and filling lines are consistent and clean. Nearly all aspects of product-machinery contact are closely examined and monitored by our quality control personnel.
Process Validation refers to the set of criteria which guide the manufacturing process. Water system pressure, temperature monitoring, storage area monitoring, and the step-by-step instructions which are followed during production are critical to the consistency of finished products.
"The Paper Trail" is the term we use to describe the chain of documentation which proves that procedures are being followed as outlined by various government agencies. Thorough auditing and analysis of paper and computer records allows us to identify problems before they happen and to maintain the highest degree of safety for our customers.