FDA 483 - Conroe Welding Supply, Inc - April 03, 2026
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Conroe Welding Supply, Inc. in Conroe, TX, a medical gas repacker, received a Form 483 with significant observations related to a complete lack of a quality unit and fundamental cGMP systems. The inspection revealed severe deficiencies across quality management, record-keeping, personnel training, equipment maintenance, and product testing, indicating a systemic failure to ensure medical gas quality. These issues suggest a high level of non-compliance with basic regulatory requirements.
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