# FDA 483 - Blaine Labs Inc - December 22, 2025

Source: https://www.keypedia.com/records/483/blaine-labs-inc/6233edca-c2e5-4389-8ac0-43037dd01b10

> FDA 483 for Blaine Labs Inc on December 22, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Blaine Labs Inc
- Inspection Date: 2025-12-22
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of Blaine Labs Inc. in Santa Fe Springs, CA, a drug manufacturer, revealed widespread deficiencies across its quality, laboratory, production, facilities, and materials systems. The firm failed to follow established procedures, conduct thorough investigations, ensure data integrity, and validate critical processes and equipment. These issues indicate a significant lack of adherence to current Good Manufacturing Practices, posing risks to drug product quality and patient safety.

## Related Documents

- [483 - 2019-09-30](https://www.keypedia.com/records/483/blaine-labs-inc/a27ac23d-c804-447d-aa97-dc5b27136fff)
- [WARNING_LETTER - 2019-09-30](https://www.keypedia.com/records/warning_letter/blaine-labs-inc/8d38c46f-25a9-47d5-9980-7ebe49c0fa06)
- [483 - 2021-08-24](https://www.keypedia.com/records/483/blaine-labs-inc/ed8c4ec5-3608-44f3-a36b-89c1bd716c9d)
- [483 - 2023-12-15](https://www.keypedia.com/records/483/blaine-labs-inc/b1bb20b9-80ff-4191-913c-8c61d3c832b7)
- [483 - 2025-12-22](https://www.keypedia.com/records/483/blaine-labs-inc/258869ff-be0e-4d20-9227-8836db856617)

## Related Officers

- [Tareq W. Haddad](https://www.keypedia.com/people/tareq-w-haddad/5dcb10ba-950c-4dea-b351-0b129675f6d2)
- [Investigator](https://www.keypedia.com/people/kham-phommachanh/cc7e728e-d2a1-469d-be3a-4f5fdd43b2dc)

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

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b