Westmoreland Review

There was one company in a city associated with Westmoreland County that received FDA citations as a result of one inspection conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 50% decrease from the number of companies cited in the previous year.

The citations in the county include:

• Personnel engaged in manufacturing, packaging, labeling and holding dietary supplements do not have the education, training, or experience to perform the person's assigned functions.
• You did not establish and follow written procedures for cleaning the physical plant.
• You did not establish and follow written procedures for calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement.

The company cited was involved in the Food and Cosmetics sector.

The company cited should take a voluntary action to correct its managing operations.

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

Company Name	Area of Business	Inspection Date	Issue Cited
American Softgels, Inc.	Food and Cosmetics	04/27/2023	Personnel - education, training, experience
American Softgels, Inc.	Food and Cosmetics	04/27/2023	Written procedures - cleaning
American Softgels, Inc.	Food and Cosmetics	04/27/2023	Procedures - calibrating instruments
American Softgels, Inc.	Food and Cosmetics	04/27/2023	Instruments - calibration
American Softgels, Inc.	Food and Cosmetics	04/27/2023	Document-equipment date of use, maintain, clean, sanitize
American Softgels, Inc.	Food and Cosmetics	04/27/2023	Specifications - component identity
American Softgels, Inc.	Food and Cosmetics	04/27/2023	Specifications-component purity, strength, composition
American Softgels, Inc.	Food and Cosmetics	04/27/2023	Specifications - contamination limits
American Softgels, Inc.	Food and Cosmetics	04/27/2023	Specifications - labels, packaging
American Softgels, Inc.	Food and Cosmetics	04/27/2023	Specifications - contamination limits
American Softgels, Inc.	Food and Cosmetics	04/27/2023	Specifications - identity, purity, strength, composition
American Softgels, Inc.	Food and Cosmetics	04/27/2023	Reserve sample -container-closure system
American Softgels, Inc.	Food and Cosmetics	04/27/2023	Written procedure quality control operations material review
American Softgels, Inc.	Food and Cosmetics	04/27/2023	Document - required operation
American Softgels, Inc.	Food and Cosmetics	04/27/2023	Master manufacturing record - each batch
American Softgels, Inc.	Food and Cosmetics	04/27/2023	Batch record - complete
American Softgels, Inc.	Food and Cosmetics	04/27/2023	Written procedures - labeling operations
American Softgels, Inc.	Food and Cosmetics	04/27/2023	Written procedures - holding
American Softgels, Inc.	Food and Cosmetics	04/27/2023	Hold - temperature, humidity, light
American Softgels, Inc.	Food and Cosmetics	04/27/2023	Hold - in-process material; temperature, humidity, light
American Softgels, Inc.	Food and Cosmetics	04/27/2023	Personnel - quality control operations; identified
American Softgels, Inc.	Food and Cosmetics	04/27/2023	Quality control operations - master manufacturing record, modifications