# FDA 483 - Blaine Labs Inc - December 15, 2023

Source: https://www.globalkeysolutions.net/records/483/blaine-labs-inc/b1bb20b9-80ff-4191-913c-8c61d3c832b7

> FDA 483 for Blaine Labs Inc on December 15, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Blaine Labs Inc
- Inspection Date: 2023-12-15
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Blaine Labs Inc, a manufacturer in Santa Fe Springs, CA, was inspected and received a Form 483 with four repeat observations. The inspection revealed significant deficiencies in the firm's quality control unit, including a lack of critical procedures, incomplete validations, and unqualified equipment. Additionally, the firm failed to validate manufacturing processes and store drug products under appropriate temperature conditions.

## Related Documents

- [483 - 2019-09-30](https://www.globalkeysolutions.net/records/483/blaine-labs-inc/a27ac23d-c804-447d-aa97-dc5b27136fff)
- [WARNING_LETTER - 2019-09-30](https://www.globalkeysolutions.net/records/warning_letter/blaine-labs-inc/8d38c46f-25a9-47d5-9980-7ebe49c0fa06)
- [483 - 2021-08-24](https://www.globalkeysolutions.net/records/483/blaine-labs-inc/ed8c4ec5-3608-44f3-a36b-89c1bd716c9d)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/darren-s-brown/389a4d1f-7f34-42cd-bdc8-5bebd41aff56)

Company: https://www.globalkeysolutions.net/companies/blaine-labs-inc/9b08b501-8f11-452d-914e-3f5339cbed81

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