# FDA 483 - SUCO, Inc. - February 25, 2024

Source: https://www.globalkeysolutions.net/records/483/suco-inc/9700cc07-a8ec-4705-b6db-8cf75d63d219

> FDA 483 for SUCO, Inc. on February 25, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SUCO, Inc.
- Inspection Date: 2024-02-25
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: SUCO, Inc. in Silver Spring, MD, was inspected regarding its manufacturing of drug products, including STIFF 'N' SORE Cream and Gel. The inspection revealed significant deficiencies in production and process controls, including a lack of process validation, inadequate equipment qualification, and insufficient written procedures for manufacturing steps and change control. Additionally, the firm failed to conduct annual product reviews and maintain complete batch production records.

## Related Documents

- [483 - 2017-08-02](https://www.globalkeysolutions.net/records/483/suco-inc/60a0dd52-6860-457d-af2e-9daf6788fc40)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/michael-o-idowu/795647ab-8f6b-47cc-ae88-3b2c61192861)
- [Claude Noel Y. Zanetsie](https://www.globalkeysolutions.net/people/claude-noel-y-zanetsie/d2341300-2c9d-4d22-bb70-5b442d4e3b70)
- [Investigator](https://www.globalkeysolutions.net/people/pushpa-s-jayasekara/cfd7d22f-b4c2-4002-ae18-b5435815d27d)

Company: https://www.globalkeysolutions.net/companies/suco-inc/72353a3f-ae10-40e9-a987-e16d075d9122

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64