L M Manufacturing LimitedFebruary 2, 2022

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

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Record Details

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.

Company: L M Manufacturing Limited
Inspection Date: February 2, 2022
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Michael A. Charles (Investigator)

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