# FDA 483 - Health Specialty - November 30, 2023

Source: https://www.keypedia.com/records/483/health-specialty/f7fa9729-c0d3-4a05-961a-a83dfcdf6c90

> FDA 483 for Health Specialty on November 30, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Health Specialty
- Inspection Date: 2023-11-30
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Health Specialty in Santa Fe Springs, CA, revealed significant deficiencies across multiple areas of their drug manufacturing operations. The firm failed to adhere to quality control procedures, provide adequate employee training, establish proper production and process controls, and ensure appropriate equipment design. Additionally, issues were noted with stability testing for expiration dates and the validation of analytical test methods, indicating a broad lack of compliance with good manufacturing practices.

## Related Officers

- [Investigator](https://www.keypedia.com/people/saied-a-asbagh/215bfa90-995f-4310-baf3-cd9d37639b7b)

Company: https://www.keypedia.com/companies/health-specialty/2d5652d1-483f-452d-a41b-5501e4ac9046

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