# FDA 483 - Rockledge Pharmaceutical Manufacturing LLC - April 24, 2025

Source: https://www.keypedia.com/records/483/rockledge-pharmaceutical-manufacturing-llc/cd8797cd-44ca-46a8-80e7-adda708136b5

> FDA 483 for Rockledge Pharmaceutical Manufacturing LLC on April 24, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rockledge Pharmaceutical Manufacturing LLC
- Inspection Date: 2025-04-24
- Product Type: drugs
- Office Name: Florida District Office
- Summary: Rockledge Pharmaceutical Manufacturing LLC, a contract manufacturer, received a Form 483 for a significant deficiency in laboratory controls. The firm failed to adequately monitor its pharmaceutical grade water system, which is critical for drug product safety and quality. This lapse involved not establishing appropriate specifications to detect objectionable organisms, potentially compromising the identity, strength, quality, and purity of their drug products.

## Related Officers

- [Angelica M. Hernandez](https://www.keypedia.com/people/angelica-m-hernandez/d66d920c-01b6-4770-a1b5-cac9a1790a0e)

Company: https://www.keypedia.com/companies/rockledge-pharmaceutical-manufacturing-llc/a5456e96-65d2-4f19-ba2f-e7cb72b32922

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9