# FDA WARNING_LETTER - United Medical Center - April 10, 2012

Source: https://www.globalkeysolutions.net/records/warning_letter/united-medical-center/9becabef-1d5b-4b11-83a8-fd92f22fd965

> FDA WARNING_LETTER for United Medical Center on April 10, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: United Medical Center
- Inspection Date: 2012-04-10
- Product Type: Devices
- Office Name: Baltimore District Office
- Summary: An FDA inspection on April 10, 2012, at Not For Profit Hospital Corp. dba United Medical Center revealed serious violations of the Mammography Quality Standards Act (MQSA). Key deficiencies included a repeat Level 1 violation for an inadequate system to provide timely mammography reports to healthcare providers within 30 days, as required by 21 CFR 900.12(c)(3)(i). A Level 2 violation noted one of ten random reports lacked an acceptable assessment category, using "Highly Suspicious for Malignancy" (21 CFR 900.12(c)(1)(iv)(E)). Additionally, repeat Level 3 violations cited the unavailability of required personnel qualification documents (21 CFR 900.12(a)(4)) and a darkroom fog density of 0.07 (21 CFR Part 900.12(e)(4)(i)). The facility's April 20, 2012, response was deemed inadequate, particularly due to the recurring nature of some violations, indicating a failure to implement permanent corrections. The FDA warned that continued non-compliance could lead to severe actions, including an Additional Mammography Review, a Directed Plan of Correction, civil money penalties up to $10,000 per violation, and suspension or revocation of the facility's FDA certificate. A Compliance Follow-up Inspection will be conducted to verify corrections.

## Related Officers

- [District Director](https://www.globalkeysolutions.net/people/evelyn-bonnin/3fdb9ef8-ea23-4a86-9176-cab37e5dea36)
- [Priscilla F. Butler](https://www.globalkeysolutions.net/people/priscilla-f-butler/5f07a00b-af3d-45d6-9aa4-ac9d6d7562a8)

Company: https://www.globalkeysolutions.net/companies/united-medical-center/fa90e580-ccd7-48a1-b62c-d418ef988605

Office: https://www.globalkeysolutions.net/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa