# FDA 483 - MARSHALLS TRADITIONAL HEALTHCARE CC - September 23, 2024

Source: https://www.keypedia.com/records/483/marshalls-traditional-healthcare-cc/05ac9d10-ecf8-4523-b93b-ad9ed2af7206

> FDA 483 for MARSHALLS TRADITIONAL HEALTHCARE CC on September 23, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MARSHALLS TRADITIONAL HEALTHCARE CC
- Inspection Date: 2024-09-23
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Marshalls Traditional Healthcare CC, an OTC drug manufacturer in Germiston, South Africa, was inspected by the FDA and received a Form 483 with eight observations. The inspection revealed significant deficiencies in production and process controls, laboratory testing, equipment design and cleaning validation, and raw material testing. These issues indicate a lack of adequate controls to ensure the identity, strength, purity, and quality of drug products, posing potential risks to product quality and patient safety.

## Related Officers

- [Josh Renzo N. Ramilo](https://www.keypedia.com/people/josh-renzo-n-ramilo/5b0850ba-e22a-42fc-9310-2beeb921f8f6)
- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

Company: https://www.keypedia.com/companies/marshalls-traditional-healthcare-cc/b53f2f2b-d0b8-4038-b432-dd3470361519

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