# FDA 483 - Identipak Inc - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/identipak-inc/5929c641-f14c-4af5-a0cf-7caffacec2db

> FDA 483 for Identipak Inc on Unknown Date. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Identipak Inc
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: 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.

## Related Documents

- [483 - 2025-12-18](https://www.globalkeysolutions.net/records/483/identipak-inc/b6e35271-2d42-4390-a373-bc1cfcfbaa5a)

## Related Officers

- [Amber Smith](https://www.globalkeysolutions.net/people/amber-smith/2395fa1b-d091-4227-a340-9d6991c394fa)

Company: https://www.globalkeysolutions.net/companies/identipak-inc/0472b825-0790-42d3-b71a-590233132990

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab