MSN Laboratories Private Limited (Formulations Division, Unit-II) – FDA 483, Nov 15, 2019
An FDA inspection of MSN Laboratories Private Limited (Formulations Division, Unit-II) in Rangareddy District, India, revealed significant deficiencies in their manufacturing of human drug products. Observations included inadequate procedures to prevent microbial contamination in sterile products, insufficient cleaning and maintenance of equipment, and inconsistent practices for visual inspection of injectable products. The firm also lacked proper statistical procedures for evaluating reserve samples, indicating a broad range of quality control issues.
- Inspection date
- November 15, 2019
- Product type
- drugs
ID · 5e02b94b-31c4-4b4f-9a3a-1ab95cb9f334
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