# FDA 483 - PRIMROSE CANDY CO - September 26, 2017

Source: https://www.keypedia.com/records/483/primrose-candy-co/c1119e36-6999-49e5-8474-898774449804

> FDA 483 for PRIMROSE CANDY CO on September 26, 2017. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: PRIMROSE CANDY CO
- Inspection Date: 2017-09-26
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of Primrose Candy Co, an OTC drug manufacturer in Chicago, revealed significant deficiencies in its quality control and manufacturing processes for menthol lozenges. The firm failed to establish adequate laboratory controls, including proper assay procedures, equipment calibration, and stability testing. Additionally, the company released drug products without proper testing and lacked process validation, indicating a systemic failure to ensure drug product quality.

## Related Documents

- [483 - 2010-12-01](https://www.keypedia.com/records/483/primrose-candy-co/f09c7e0a-9588-493d-85dd-f02bf98701aa)
- [483 - 2012-05-23](https://www.keypedia.com/records/483/primrose-candy-co/dc617174-8bf5-435a-a87c-f0253f03d446)
- [EIR - 2021-02-25](https://www.keypedia.com/records/eir/primrose-candy-co/6ca15043-322c-46f5-b2fb-cfbaedddc4f0)
- [483 - 2021-02-25](https://www.keypedia.com/records/483/primrose-candy-co/32374598-37f5-41bd-bf2d-c3f0e659222a)
- [483 - 2021-11-19](https://www.keypedia.com/records/483/primrose-candy-co/ee89257f-e18b-44f4-90ec-4e14961ca71b)

## Related Officers

- [investigator](https://www.keypedia.com/people/nicholas-p-diorio/fba94f6f-38b9-4d30-b8a1-d6c9d4769e49)

Company: https://www.keypedia.com/companies/primrose-candy-co/3c068e82-ef91-4264-aea2-355bc538aa3c

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669