# FDA WARNING_LETTER - So-Low Environmental Equipment Co. Inc. - April 17, 2013

Source: https://www.keypedia.com/records/warning_letter/so-low-environmental-equipment-co-inc/1b34f2eb-d81e-48e5-8c11-8ecfedc44663

> FDA WARNING_LETTER for So-Low Environmental Equipment Co. Inc. on April 17, 2013. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: So-Low Environmental Equipment Co. Inc.
- Inspection Date: 2013-04-17
- Product Type: Devices
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of So-Low Environmental Equipment Co., Inc. from April 9-17, 2013, revealed that their ultra-low temperature freezers for medical applications are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's May 1, 2013, response to the FDA 483 was deemed inadequate.

Key violations include:
- **Corrective and Preventive Actions (CAPA):** Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)), with no documented review of data sources or proper use of the CAPA log.
- **Complaint Handling:** Inadequate maintenance of complaint files and failure to review/evaluate all complaints for investigation necessity (21 CFR 820.198(a), (b)), with missing documentation and lack of review for numerous complaints.
- **Training:** Failure to establish training procedures and ensure personnel are adequately trained (21 CFR 820.25(b)), evidenced by incomplete competency forms and lack of quality system training.
- **Organizational Structure:** Inadequate organizational structure to ensure device compliance (21 CFR 820.20(b)), lacking a dedicated quality department or personnel.
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## Related Officers

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

Company: https://www.keypedia.com/companies/so-low-environmental-equipment-co-inc/5900b189-13f8-4698-a558-991fd2d07193

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