# FDA WARNING_LETTER - Noble Anesthesia-Air, Inc. - June 26, 2012

Source: https://www.keypedia.com/records/warning_letter/noble-anesthesia-air-inc/0b2a5733-c5f2-497b-af10-958df14995f2

> FDA WARNING_LETTER for Noble Anesthesia-Air, Inc. on June 26, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Noble Anesthesia-Air, Inc.
- Inspection Date: 2012-06-26
- Product Type: Devices
- Office Name: Florida District Office
- Summary: On September 12, 2012, the FDA issued a Warning Letter to Noble Anesthesia-Air, Inc. following an inspection from June 19-26, 2012. The inspection revealed that the firm's devices, including the Adult SNOR-TAL, SNOR-SCOPE, SNOR-PAC, SNOR-CAL, and SNOR-SCOPE PLUS, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations included:
1.  Failure to establish and maintain design control procedures (21 CFR 820.30(a)(1)).
2.  Failure to establish and maintain adequate procedures for design input requirements, including review and approval (21 CFR 820.30(c)).
3.  Failure to establish and maintain adequate procedures for design verification and documentation in the Design History File (DHF) (21 CFR 820.30(f)).
4.  Failure to establish and maintain design validation procedures, including risk analysis and documentation (21 CFR 820.30(g)).
5.  Failure to establish and maintain procedures for design transfer to production specifications (21 CFR 820.30(h)).
6.

## Related Officers

- [District Director](https://www.keypedia.com/people/emma-r-singleton/e0b72aba-caa5-4cf8-8beb-6f93f6654e59)

Company: https://www.keypedia.com/companies/noble-anesthesia-air-inc/30f5a303-5c7f-4749-814c-58285c5f839c

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9