# FDA 483 - DPT Laboratories, Ltd - February 07, 2020

Source: https://www.keypedia.com/records/483/dpt-laboratories-ltd/9f42001b-4d00-4e49-a18d-de315eb4f843

> FDA 483 for DPT Laboratories, Ltd on February 07, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DPT Laboratories, Ltd
- Inspection Date: 2020-02-07
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: DPT Laboratories, Ltd in San Antonio, TX, a prescription drug manufacturer, was cited with six observations during an FDA inspection. The observations primarily concern deficiencies in the quality control unit's written procedures, review processes, and thoroughness of investigations, as well as issues with laboratory records, test method validation, and master production records. These issues indicate significant gaps in the firm's quality system and control over manufacturing processes.

## Related Documents

- [EIR - 2020-02-07](https://www.keypedia.com/records/eir/dpt-laboratories-ltd/15710107-f018-4e1a-91b9-fe1e58859361)

## Related Officers

- [Principal Consultant](https://www.keypedia.com/people/stephen-d-brown/01ff1439-f6d7-4501-a104-573dae30d306)
- [investigator](https://www.keypedia.com/people/youmin-wang/a61763d9-5354-4e2f-9909-d2bacdd5c34d)

Company: https://www.keypedia.com/companies/dpt-laboratories-ltd/0a6b4d0a-ad7e-4f4f-ab10-34e0ef9913d4

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9