Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3014210753.
Observations7
Issue DateSeptember 18, 2025
StatusNo Warning Letter
Establishment TypeSterile Drug Manufacturer
Related Inspections3
Establishment Details
Firm
Immacule Lifesciences Private Limited
Location
Nalagarh, India
FEI Number
3014210753
Establishment Type
Sterile Drug Manufacturer
Product Type
Drugs
Issue Date
September 18, 2025
Country
India
Inspection History, 2022 to 2025
VAI2
OAI1
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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