Inspections

LifeSan by the Numbers: An Unmatched Track Record of Regulatory Excellence

At LifeSan Clinical Research, compliance isn't just a goal—it is a measurable standard. Our perfect inspection metrics demonstrate our absolute data integrity and world-class quality systems.

100% Success in Global Inspections

  • 9 Successful USFDA Inspections: We have achieved a 100% pass rate across 9 comprehensive USFDA inspections since our inception.

  • 5 Unannounced USFDA Inspections: Our systems are permanently inspection-ready, as demonstrated by clearing 5 unannounced USFDA inspections with zero friction.

  • 0 Observations (June 2025): Our latest 5-day USFDA Bioresearch Monitoring (BIMO) audit concluded with a perfect score:

    • 0 Form 483 Observations

    • 0 Verbal Discussion Items

    • 0 Post-Audit Recommendations

Multi-Agency Approvals & Global Submissions

  • 6 Major International Accreditations: Our facility stands routinely inspected and fully approved by 6 premier international regulatory bodies:

    • European Medicines Agency (EMA)

    • Medicines and Healthcare products Regulatory Agency (MHRA, UK) with recent inspection in January 2026

    • South African Health Products Regulatory Authority (SAHPRA)

    • Instituto de Salud Pública (ISP, Chile)

    • National Pharmaceutical Regulatory Agency (NPRA, Malaysia)

    • Central Drugs Standard Control Organisation (CDSCO, India)

    • GCC (Oman): Awarded final accreditation based on a successful remote assessment

  • All Landmark Global Agencies Supported: Data generated at LifeSan has seamlessly backed successful dossiers and product clearances for stringent global agencies:

    • USFDA including PEPFAR

    • MHRA

    • EMA

    • Health Canada

    • Therapeutic Goods Administration (TGA, Australia)

    • Regulatory agencies spanning the CIS Countries

    • NPRA, Malaysia

    • NMPA, China

 

Inspections Listing

Name of the regulatory authorities/ agencies
Dates of inspection
Outcome
 
MHRA, UK
19-Jan-26 to 23-Jan-26
Successful, GCP inspection closure letter is received.
 
GCC (Oman)
N/AP- based on remote assessment
Successful, final accreditation letter received.
 
USFDA
16-Jun-25 to 20-Jun-25
No (483) observations, no discussion items and no recommendations. Outcome: Successful, NAI EIR received.
 
NPRA, Malaysia
12-Aug-24 to 16-Aug-24
Successful, final accreditation letter received
 
USFDA
20-Feb-23 to 24-Feb-23 (Bioanalytical)
No (483) observations, no discussion items and no recommendations. Outcome: Successful, NAI Establishment Inspection Report (EIR) received.
 
USFDA
05-Dec-22 to 09-Dec-22 (Clinical)
No (483) observations, no discussion items and no recommendations. Outcome: Successful, NAI Letter of successful outcome received. Establishment Inspection Report (EIR) received.
 
ISP, Chile
17-Oct-21 to 21-Oct-21 (Clinical)
No observations. Recommendations suggested and implemented. Letter of recognition received.
 
USFDA
26-Aug-19 to 30-Aug-19 (Clinical)
No (483) observations for clinical section. Establishment Inspection Report (EIR) received.
 
USFDA
05-Aug-19 to 08-Aug-19 (Bioanalytical)
Data integrity inspection with no 483 observations for bioanalytical section.
 
USFDA
28-Nov-17 to 01-Dec-17 (Clinical)
A solitary 483 observation was provided in clinical section, which has been cleared. Establishment Inspection Report (EIR) received. ANDA approved
 
USFDA
11-Sep-17 to 15-Sep-17 (Bioanalytical)
Data integrity inspection with no 483 observations for bioanalytical section. Establishment Inspection Report (EIR) received.
 
MHRA [Medicine and Healthcare products Regulatory Agency] – United Kingdom
28-Apr-14 to 02-May-14
GCP inspection closed with no observations pending.
 
BfArM [Federal Institute for Drugs and Medical Devices] – Germany
28-Apr-14 to 02-May-14
GCP inspection closed with no observations pending.
 
USFDA
10-Dec-12 to 14-Dec-12 (Clinical)
GCP inspection closed with no observations pending. Establishment Inspection Report (EIR) received.
 
USFDA 
17-Sep-12 to 21-Sep-12 (Bioanalytical)
GCP inspection closed with no observations pending. Establishment Inspection Report (EIR) received.
 
Medicines Central Council [MCC]- South Africa
05-Dec-11 to 07-Dec-11
GCP inspection closed with no observations pending.
 
CDSCO (Central Drug Standard Control Organization, India)
Inspection carried out during 17-Mar-25 to 19-Mar-25
Successful, letter of renewal of registration is received
 
 
11-Jan-21
Approval for additional beds [total beds 50]
 
 
14-Jan-20
Approval granted and Registration of LifeSan at CDSCO
 
 
09-Sep-16
Approval granted.
 
 
18-Jun-14
Approval granted.
 
 
01-Oct-12
Approval granted.
 
 
09-Dec-10
Approval granted.
 
 
29-Aug-08
Approval granted.