# FDA 483 - Medical Components, Inc dba MedComp - June 14, 2017

Source: https://www.keypedia.com/records/483/medical-components-inc-dba-medcomp/c9914c92-f590-40de-9231-ee6703feb091

> FDA 483 for Medical Components, Inc dba MedComp on June 14, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medical Components, Inc dba MedComp
- Inspection Date: 2017-06-14
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Medical Components, Inc dba MedComp in Harleysville, PA, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately document and implement corrective and preventive actions, particularly concerning supplier issues. Additionally, the inspection found a lack of required quality audits, insufficient evaluation of potential suppliers, and untimely investigation of nonconforming products, indicating systemic control breakdowns.

## Related Documents

- [WARNING_LETTER - 2015-02-12](https://www.keypedia.com/records/warning_letter/medical-components-inc-dba-medcomp/de096af7-5bec-4f51-9a87-00307b10f914)

## Related Officers

- [Investigator at US Food and Drug Administration](https://www.keypedia.com/people/brian-s-keefer/4fec578b-ca72-4d79-8634-3a9fe7ecd9a5)
- [Jacob M Dyer](https://www.keypedia.com/people/jacob-m-dyer/e3ca27e3-e0b1-4db8-9cbe-cfaff90b83cf)

Company: https://www.keypedia.com/companies/medical-components-inc-dba-medcomp/24de0555-f79b-48bc-93e9-8b266ba67d44

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8