483
W & R Investments LLC d.b.a. Laser EngineeringW & R Investments LLC d.b.a. Laser Engineering – FDA 483, Oct 13, 2022
Record Details
An FDA inspection of W & R Investments LLC d.b.a. Laser Engineering in Milford, MA, identified a significant issue with the firm's complaint handling procedures. The company failed to establish adequate procedures for receiving, reviewing, and evaluating complaints, specifically lacking a time-frame objective for complaint file closure. This deficiency led to numerous complaint files remaining open for extended periods, potentially resulting in missed Medical Device Reports (MDRs).
- Inspection date
- October 13, 2022
- Product type
- device
- Person
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ID · b765284d-2939-4c8f-a459-d48dc4ac44b7
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