483
Identipak IncFDA 483 - Identipak Inc
Record Details
Identipak Inc, a medical device manufacturer in McAllen, TX, received a Form FDA 483 citing two significant quality system deficiencies. The firm lacked established procedures for the rework and reevaluation of nonconforming medical devices. Additionally, Identipak Inc failed to document the evaluation of its suppliers for incoming materials.
- Company
- Identipak Inc
- Product Type
- Device
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ID · 5929c641-f14c-4af5-a0cf-7caffacec2db