# FDA WARNING_LETTER - Spacelabs Healthcare Inc - April 02, 2014

Source: https://www.keypedia.com/records/warning_letter/spacelabs-healthcare-inc/ea469af3-62b0-4e71-9927-8ffef17d2531

> FDA WARNING_LETTER for Spacelabs Healthcare Inc on April 02, 2014. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Spacelabs Healthcare Inc
- Inspection Date: 2014-04-02
- Product Type: Devices
- Office Name: Seattle District Office
- Summary: This FDA Warning Letter, dated August 11, 2014, is an amendment to an August 5, 2014 letter, correcting a typographical error and extending the response deadline. It resulted from an inspection of a Snoqualmie, Washington firm manufacturing patient monitoring devices (e.g., Qube, Ultraview SL, ?lance Central Station) from February 12 to April 2, 2014. The inspection found the devices adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Violations include:
1.  **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: CAPAs were closed without implementing corrective actions (e.g., CAPA 31920, 24340) and effectiveness was not verified/validated (e.g., CAPA 31363).
2.  **Failure to control nonconforming product (21 CFR 820.90(a))**: Out-of-specification components were accepted without Nonconforming Materials Records (NMRs).
3.  **Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a))**: Service

## Related Officers

- [Deepak Chopra](https://www.keypedia.com/people/deepak-chopra/27601f4f-42a3-4650-bc9d-69e1ec255fea)
- [Jessica L. Kocian](https://www.keypedia.com/people/jessica-l-kocian/426846c6-2341-4991-8c1e-3b57ae35964d)
- [Miriam R. Burbach](https://www.keypedia.com/people/miriam-r-burbach/68959b72-6f58-4d4b-9329-5109ffe8a649)
- [Leslie Honda](https://www.keypedia.com/people/leslie-honda/da54333b-9bff-4e92-9597-36873a2f598b)

Company: https://www.keypedia.com/companies/spacelabs-healthcare-inc/67200940-c273-47be-8363-7cd301f7c9fb

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913