483
Nelson Environmental Technologies, IncFDA 483 - Nelson Environmental Technologies, Inc
Record Details
An FDA inspection of Nelson Environmental Technologies, Inc., a device manufacturer in McAllen, TX, revealed significant deficiencies in their quality system. Observations included a lack of documented supplier evaluations, inadequate equipment maintenance schedules, and failures in controlling in-process product temperatures. Additionally, the firm lacked established procedures for finished device and incoming product acceptance, and documented acceptance activities contained inaccuracies.
- Product Type
- Device
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ID · e1642d4a-4d70-4a58-ab55-0e1b9255ae3a