# FDA 483 - McCallum Manufacturing Limited - September 15, 2023

Source: https://www.keypedia.com/records/483/mccallum-manufacturing-limited/b3676198-0038-4fb3-a621-0786996ab0fd

> FDA 483 for McCallum Manufacturing Limited on September 15, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: McCallum Manufacturing Limited
- Inspection Date: 2023-09-15
- Product Type: drugs
- Office Name: Food and Drug Administration
- Summary: An FDA inspection of McCallum Manufacturing Ltd, an OTC drug and cosmetic manufacturer located in Barnsley, UK, was conducted from September 11-15, 2023. The inspection revealed significant deficiencies in the firm's adherence to Current Good Manufacturing Practices (CGMP), with many observations being repeats from prior inspections. Key violations included the failure to adequately test finished drug products for identity and strength, and raw materials for purity and quality prior to release, often relying on unverified supplier data. The company also lacked validated cleaning procedures for shared manufacturing equipment, posing a risk of cross-contamination.

Major shortcomings were identified within the Quality Control Unit, which exhibited a lack of defined responsibilities, comprehensive written procedures for critical operations such as training, change control, and handling out-of-specification results, and proper quality agreements with contract laboratories. The firm failed to conduct process validation for its drug products, maintain complete batch records, or implement an effective stability testing program. Equipment calibration and the training and qualification of personnel in CGMP principles were also found to be inadequate.

To address these findings, McCallum Manufacturing Ltd must implement robust testing protocols for all materials and products, validate cleaning procedures, establish a fully functional and independent Quality Unit with documented procedures, conduct process and cleaning validations, improve batch record documentation, establish a compliant stability program, ensure all equipment is calibrated, and provide comprehensive CGMP training to all relevant personnel. These actions are essential to ensure the safety, quality, and efficacy of its drug products for the U.S. market.

## Related Documents

- [483 - 2017-07-28](https://www.keypedia.com/records/483/mccallum-manufacturing-limited/2e89fa23-20a7-4a0b-9e6d-9ee86c064dfb)
- [483 - 2023-09-15](https://www.keypedia.com/records/483/mccallum-manufacturing-limited/14d5e562-f326-451d-972a-d243474eca14)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)
- [Director](https://www.keypedia.com/people/joann-m/0a459cd4-7849-4687-8811-4868144e3be3)

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

Office: https://www.keypedia.com/offices/food-and-drug-administration/437fdb2a-5048-42aa-aaea-ea28efe65516