# FDA 483 - Piramal Critical Care, Inc. - September 27, 2023

Source: https://www.globalkeysolutions.net/records/483/piramal-critical-care-inc/a52f2662-2933-4bb5-ac66-484796ecb889

> FDA 483 for Piramal Critical Care, Inc. on September 27, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Piramal Critical Care, Inc.
- Inspection Date: 2023-09-27
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Piramal Critical Care, Inc. in Bethlehem, PA, was inspected by the FDA, resulting in two observations. The inspection revealed deficiencies in equipment maintenance record-keeping and a lack of written procedures for production and process controls, specifically concerning an inspection unit for drug products. These issues indicate potential risks to drug product quality and compliance.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/amy-n-chen/c3515e0e-dbb9-4540-bd2b-82c06d00dd42)

Company: https://www.globalkeysolutions.net/companies/piramal-critical-care-inc/9cb01f72-bedf-48bc-acb6-d2d9933a3f0f

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8