483
MSN Laboratories Private Limited (Formulations Division, Unit-II)MSN Laboratories Private Limited (Formulations Division, Unit-II) – FDA 483, Jun 20, 2019
Record Details
An FDA inspection of MSN Laboratories Pvt. Ltd. (Formulations Division, Unit-II) in Rangareddy District, Telangana, India, identified a significant concern regarding the manufacturing process. The firm failed to establish appropriate time limits and other critical parameters for production equipment during equipment qualification. This deficiency impacts the assurance of drug product quality.
- Inspection date
- June 20, 2019
- Product type
- drugs
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ID · b54c9c76-a591-428d-9e20-8fadbfdd0c09
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