# FDA WARNING_LETTER - Progressive Medical Inc - September 01, 2011

Source: https://www.keypedia.com/records/warning_letter/progressive-medical-inc/3280e1cd-b8e3-4a05-92a2-1d280ad114d8

> FDA WARNING_LETTER for Progressive Medical Inc on September 01, 2011. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Progressive Medical Inc
- Inspection Date: 2011-09-01
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: On January 10, 2012, the FDA issued a Warning Letter to Progressive Medical, Inc. following an inspection from August 30 to September 1, 2011. The inspection determined that the firm manufactures various medical devices, including the MedPro AccuFlo Elastomeric Infusion Pump and Progressive Medical Disposable Uterine Manipulator, which are considered adulterated under Section 501(h) of the Act due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include:
1.  Failure to establish and maintain corrective and preventive action procedures (21 CFR 820.100(a)).
2.  Failure to establish and maintain design and development plans (21 CFR 820.30(b)), specifically lacking design plans for contract-manufactured products.
3.  Failure to define control over suppliers and contractors (21 CFR 820.50(a)(2)), including no procedures for qualifying contractors, no documentation for manufacturer evaluation, and no approval of contract manufacturers. Medpro International also failed to obtain premarket clearance for AccuFlo and AccuRx pumps.
4.  Failure to establish and maintain document control procedures (21 CFR 820.40), with several procedures lacking approval dates and/or signatures.
5.  Failure of management to review

## Related Officers

- [District Director](https://www.keypedia.com/people/john-w-thorsky/7a765cf2-aafc-48f7-98f5-172795a7d0d8)

Company: https://www.keypedia.com/companies/progressive-medical-inc/f4792582-017f-4fb5-b4c5-b20a72cadbd0

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861