# FDA 483 - Medco Manufacturing - September 07, 2023

Source: https://www.keypedia.com/records/483/medco-manufacturing/cb3c5732-6230-4272-8d2e-8f817de4dce7

> FDA 483 for Medco Manufacturing on September 07, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medco Manufacturing
- Inspection Date: 2023-09-07
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Medco Manufacturing, a medical device manufacturer in Spring, TX, was inspected by the FDA and received a Form 483 with seven observations, many of which were repeat findings. The inspection revealed significant deficiencies across multiple quality system areas, including design change, finished device acceptance, corrective and preventive actions, device history records, servicing procedures, quality audits, and management review. These issues indicate a systemic failure to maintain an effective quality system for their Class II MEDCO Aspirator IV portable aspiration pump.

## Related Documents

- [483 - 2019-05-13](https://www.keypedia.com/records/483/medco-manufacturing/169f1268-3768-4c03-8a25-97687271beb3)

## Related Officers

- [Jocelyn C. Turner](https://www.keypedia.com/people/jocelyn-c-turner/7e39f6e0-9750-4460-8a4e-27ee9306b77e)

Company: https://www.keypedia.com/companies/medco-manufacturing/3dbeb100-78b8-4035-9c32-dc9b63391793

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab