# FDA WARNING_LETTER - Sea-Long Medical Systems, LLC - September 08, 2022

Source: https://www.globalkeysolutions.net/records/warning_letter/sea-long-medical-systems-llc/4da7446c-ff6d-488e-85f0-8ae9f13f50a9

> FDA WARNING_LETTER for Sea-Long Medical Systems, LLC on September 08, 2022. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Sea-Long Medical Systems, LLC
- Inspection Date: 2022-09-08
- Product Type: Devices
- Office Name: Division of Medical Device and Radiological Health Operations East
- Summary: The FDA issued a Warning Letter to Sea-Long Medical Systems, LLC, following an inspection from August 22 to September 8, 2022. The firm manufactures Sea-Long Medical Treatment Hoods (latex and non-latex, single and multi-patient neck seals with hoods). These devices are deemed adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(o), § 352(c), and § 352(t)(2).

Key violations include:
1. **Complaint Handling (21 CFR 820.198(a)):** Failure to establish and maintain adequate complaint procedures, lacking documentation of investigation details, root cause analysis, and corrective/preventive actions for five complaint records. Missing complaint logs and product/serial IDs.
2. **Process Validation (21 CFR 820.75(a)):** Failure to validate processes where results cannot be fully verified by inspection and test.
3. **Design Change (21 CFR 820.30(i)):** Absence of established procedures for design changes for Treatment Hoods.
4. **Corrective and Preventive Action (CAPA) (21 CFR

## Related Documents

- [483 - 2022-09-08](https://www.globalkeysolutions.net/records/483/sea-long-medical-systems-llc/0df36c23-7548-49e2-81b2-a94d17e810e3)
- [483 - 2024-11-05](https://www.globalkeysolutions.net/records/483/sea-long-medical-systems-llc/e1934ae8-6c91-496b-9460-842b6618c0f9)

## Related Officers

- [Office Director](https://www.globalkeysolutions.net/people/malvina-b-eydelman/3b4d6cfe-2cb5-42fb-9d60-a1c7f2300f60)
- [Christopher L. Austin](https://www.globalkeysolutions.net/people/christopher-l-austin/9598f308-0ccf-4688-8c32-112116a601e3)
- [Program Division Director](https://www.globalkeysolutions.net/people/shari-j-shambaugh/aaea1185-eca8-41f8-bec7-d5d0024b582d)

Company: https://www.globalkeysolutions.net/companies/sea-long-medical-systems-llc/7fbe11f1-7cc2-4bc6-aca1-2a27251c0074

Office: https://www.globalkeysolutions.net/offices/division-of-medical-device-and-radiological-health-operations-east/360ecccc-5273-4159-86e7-9eaeb8d41456