# FDA WARNING_LETTER - SCM True Air Technologies LLC - May 24, 2013

Source: https://www.globalkeysolutions.net/records/warning_letter/scm-true-air-technologies-llc/63e0cd22-da38-41f8-bc4e-4587f9cd2dc1

> FDA WARNING_LETTER for SCM True Air Technologies LLC on May 24, 2013. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: SCM True Air Technologies LLC
- Inspection Date: 2013-05-24
- Product Type: Devices
- Office Name: Cincinnati District Office
- Summary: On May 6-24, 2013, an FDA inspection of SCM True Air Technologies, Inc. in Louisville, KY, revealed that their bariatric beds and low air loss controllers are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations include:
1.  Failure to control nonconforming product (21 CFR 820.90(a)): Procedures were inadequate, and 34 of 48 nonconforming beds were not evaluated or investigated.
2.  Failure to establish complaint handling procedures (21 CFR 820.198(a)): A complaint regarding 48 bariatric beds with defects was not entered into the system.
3.  Inadequate design input procedures (21 CFR 820.30(c)): Design procedures lacked defined performance, safety, environmental, and physical characteristics, and were not fully implemented.
4.  Inadequate design output procedures (21 CFR 820.30(d)): Procedures lacked acceptance criteria, and design outputs like instructions for use and specifications were incomplete.
5.  Failure to verify device design (21 CFR 820.30(f)):

## Related Officers

- [District Director](https://www.globalkeysolutions.net/people/paul-j-teitell/5de80a65-d370-4a60-8080-21befa356d9b)

Company: https://www.globalkeysolutions.net/companies/scm-true-air-technologies-llc/26027609-9286-409e-af8d-8dd810087868

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22