# FDA 483 - L M Manufacturing Limited - February 02, 2022

Source: https://www.globalkeysolutions.net/records/483/l-m-manufacturing-limited/9fdfb9f1-9722-47a8-9b0b-b5ba9bd0814d

> FDA 483 for L M Manufacturing Limited on February 02, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: L M Manufacturing Limited
- Inspection Date: 2022-02-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: L M Manufacturing Limited, a drug manufacturer in Northampton, United Kingdom, received a Form 483 for deficiencies in manufacturing process control and laboratory test method validation. The inspection revealed a lack of established control procedures and validated operating ranges for manufacturing processes, alongside unvalidated microbial identification methods and laboratory software. These issues highlight significant concerns regarding product quality and data integrity.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/michael-a-charles/f83241f0-ae3b-4535-ac03-e790bbf666ca)

Company: https://www.globalkeysolutions.net/companies/l-m-manufacturing-limited/5676b03e-c76c-4b44-b501-799ab3a3f165

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1