# FDA 483 - Pharmadepot Labs, LLC - June 18, 2024

Source: https://www.keypedia.com/records/483/pharmadepot-labs-llc/ac4dba6b-9f58-4eaa-92d4-e6a938381033

> FDA 483 for Pharmadepot Labs, LLC on June 18, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmadepot Labs, LLC
- Inspection Date: 2024-06-18
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Pharmadepot Labs, LLC in San Diego, CA, was inspected by the FDA from June 10-18, 2024, and received a Form 483 with five observations. The inspection revealed significant deficiencies in the firm's quality control unit, production and process controls, laboratory controls, batch recordkeeping, and equipment calibration procedures, indicating a lack of fundamental GMP compliance for OTC drug manufacturing.

## Related Officers

- [Claudia M. Perez-Kasmarski](https://www.keypedia.com/people/claudia-m-perez-kasmarski/ee989ba2-eb7a-47ae-8be5-7a28f748343b)

Company: https://www.keypedia.com/companies/pharmadepot-labs-llc/be7c4d30-3242-4c88-8f6b-390cc23b7e50

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6