483
Bose CorporationBose Corporation – FDA 483, Nov 12, 2021
Record Details
Bose Corporation in Framingham, MA, underwent an FDA inspection of its manufacturing facility. The inspection revealed that procedures for device history records for its SoundControl Hearing Aids were not adequately established. This indicates a deficiency in the firm's quality system regarding documentation and recordkeeping.
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ID · ddd75443-3016-4cf5-b285-7d447a801797
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