# FDA 483 - McCallum Manufacturing Limited - July 28, 2017

Source: https://www.keypedia.com/records/483/mccallum-manufacturing-limited/2e89fa23-20a7-4a0b-9e6d-9ee86c064dfb

> FDA 483 for McCallum Manufacturing Limited on July 28, 2017. Product: cosmetics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: McCallum Manufacturing Limited
- Inspection Date: 2017-07-28
- Product Type: cosmetics
- Office Name: Human Foods Program
- Summary: McCallum Manufacturing Ltd, an OTC and Cosmetics manufacturer in Barnsley South Yorkshire, was cited with 11 observations during an FDA inspection from July 24-28, 2017. The inspection revealed significant deficiencies in manufacturing process validation, quality agreements, equipment cleaning validation, record-keeping, material testing, and overall quality assurance procedures. These issues indicate a lack of robust quality control and documentation practices for their (b)(4) US products.

## Related Documents

- [483 - 2023-09-15](https://www.keypedia.com/records/483/mccallum-manufacturing-limited/14d5e562-f326-451d-972a-d243474eca14)

## Related Officers

- [Azza Talaat](https://www.keypedia.com/people/azza-talaat/91f4d4f9-b0f3-4e9c-8c05-2bfe40507dfd)

Company: https://www.keypedia.com/companies/mccallum-manufacturing-limited/55b264fd-b86c-4ee6-8cf1-653819354ead

Office: https://www.keypedia.com/offices/human-foods-program/8bff4a0b-7bed-449c-b67b-56a83c96a324