Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3007490529.
Observations12
Issue DateSeptember 17, 2024
StatusNo Warning Letter
Related Inspections6
Establishment Details
Firm
Aspen SA Sterile Operations (Pty) Ltd.
Location
Port Elizabeth, -, South Africa
FEI Number
3007490529
Product Type
Drugs
Issue Date
September 17, 2024
Country
South Africa
Inspection History, 2012 to 2026
NAI2
VAI2
OAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.