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

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