# FDA 483 - Private Label Select Ltd. Co. - July 23, 2021

Source: https://www.globalkeysolutions.net/records/483/private-label-select-ltd-co/a1bbcb53-0010-43ee-a495-63100623fd8b

> FDA 483 for Private Label Select Ltd. Co. on July 23, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Private Label Select Ltd. Co.
- Inspection Date: 2021-07-23
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Private Label Select Ltd. Co., an OTC drug manufacturer in Taos, NM, was cited for numerous deficiencies during an FDA inspection. The firm failed to validate manufacturing processes, investigate out-of-specification results, and conduct adequate stability studies for its drug products. Significant issues were also noted in laboratory controls, equipment design and cleaning, complaint handling, and quality unit oversight, indicating a systemic lack of adherence to GMPs.

## Related Officers

- [Joel D. Hustedt](https://www.globalkeysolutions.net/people/joel-d-hustedt/29440042-08dd-4dce-be48-b55f8e1d7080)

Company: https://www.globalkeysolutions.net/companies/private-label-select-ltd-co/6c6847f8-24ef-43d2-93eb-6fd4ca9da878

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