# FDA 483 - DJ Acquisition FTT LLC, DBA Weco Manufacturing Group - Hennrietta - October 12, 2023

Source: https://www.keypedia.com/records/483/dj-acquisition-ftt-llc-dba-weco-manufacturing-group-hennrietta/034c418f-7b92-49ef-b398-6ffe5b204ef8

> FDA 483 for DJ Acquisition FTT LLC, DBA Weco Manufacturing Group - Hennrietta on October 12, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DJ Acquisition FTT LLC, DBA Weco Manufacturing Group - Hennrietta
- Inspection Date: 2023-10-12
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: This 483 report for DJ Acquisition FTT LLC, DBA Weco Manufacturing Group - Henrietta, a medical device manufacturer in Rochester, NY, details significant deficiencies in their quality system. The inspection revealed inadequate procedures for controlling nonconforming products and corrective and preventive actions. Furthermore, the firm failed to document critical design control activities, including design validation, verification, inputs, reviews, and plans for their anoscope products.

## Related Officers

- [Matthew D. Schnittker](https://www.keypedia.com/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.keypedia.com/companies/dj-acquisition-ftt-llc-dba-weco-manufacturing-group-hennrietta/6381fc4c-164d-4c48-b5b0-879d535a31c0

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961