# FDA 483 - PIC USA Inc - January 30, 2025

Source: https://www.keypedia.com/records/483/pic-usa-inc/086804c9-23a9-4a09-afaf-2743771eb1a3

> FDA 483 for PIC USA Inc on January 30, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PIC USA Inc
- Inspection Date: 2025-01-30
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: PIC USA Inc, a production facility in Adolphus, KY, was cited with three observations during an FDA inspection from January 28-30, 2025. The inspection revealed significant deficiencies in the firm's written procedures, particularly concerning the quality control unit, production and process controls, and labeling processes for drug products. These issues indicate a lack of adequate control over critical manufacturing operations.

## Related Officers

- [William F. Lagud](https://www.keypedia.com/people/william-f-lagud/c90c4bd6-bb56-4a60-a5f8-cbc648bb8dbe)

Company: https://www.keypedia.com/companies/pic-usa-inc/8a560ea6-3e6c-47a1-8adb-ce3646e6e793

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22