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

Source: https://www.keypedia.com/records/483/pharmadepot-labs-llc/afd38b36-1fd8-4eec-8fb5-99b742c75ed7

> 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: Los Angeles District Office
- Summary: Pharmadepot Labs, LLC was inspected by the FDA from June 10 to June 18, 2024, revealing critical deficiencies in its manufacturing operations. The inspection highlighted a fundamental lack of a functional quality control unit, with no qualified personnel or established procedures for essential functions such as complaint handling, adverse event reporting, deviations, recalls, and internal audits. The company also failed to implement a supplier qualification program for active pharmaceutical ingredients (APIs) and did not have a stability testing program for its Over-The-Counter (OTC) drug products.

Further observations included the absence of written production and process control procedures, specifically the lack of process validation for finished drug products manufactured since 2020. Laboratory controls were deemed inadequate, as the firm relied solely on supplier Certificates of Analysis for incoming APIs without performing identity testing or qualifying suppliers. The inspection also found that batch production and control records were not prepared for multiple drug product batches. Additionally, the company lacked written procedures and records for the calibration of instruments, including scales and filling machines used in production. To meet regulatory requirements, Pharmadepot Labs, LLC must promptly implement comprehensive corrective actions to address these significant quality system, manufacturing, and documentation shortcomings.

## Related Documents

- [483 - 2024-06-18](https://www.keypedia.com/records/483/pharmadepot-labs-llc/ac4dba6b-9f58-4eaa-92d4-e6a938381033)

## Related Officers

- [Eduardo Ruiz](https://www.keypedia.com/people/eduardo-ruiz/401921f2-6848-4fff-b48e-32402cbb235c)
- [Director](https://www.keypedia.com/people/joann-m/0a459cd4-7849-4687-8811-4868144e3be3)
- [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/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b