USFDA inspection of pharmacovigilance system at New Jersey office closes with nil observations
USFDA inspected Zydus' pharmacovigilance and post-marketing surveillance system at its New Jersey, USA office from 22 to 25 September 2026.
By ScoutQuest · · 1 min read
- Inspection Period
- 22 to 25 September 2026
- Inspection Location
- New Jersey, USA office
- System Inspected
- Pharmacovigilance and post-marketing surveillance system
- Inspection Outcome
- NIL observations
- Form 483 Issues
- No Form 483 issues raised
What happened
The USFDA conducted an onsite inspection of the pharmacovigilance and post-marketing surveillance system at the company's office in New Jersey, USA.
- Inspection period: 22 September to 25 September 2026
- Outcome: closed with NIL observations
What pharmacovigilance means
Pharmacovigilance is the system a drugmaker uses to collect, assess and report side effects and safety issues once its medicines are already being sold. Post-marketing surveillance is the ongoing monitoring of those products in the market. The USFDA inspects these systems separately from manufacturing plants.
Why it matters
A close with nil observations means the regulator did not record any deficiencies at the end of the inspection. Adverse findings in such inspections can lead to follow-up regulatory action; a clean close avoids that route for this site and system.
The disclosure was made under Regulation 30 of the SEBI Listing Obligations and Disclosure Requirements Regulations, 2015.
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More numbers
- USFDA observations at close of inspectionNIL observations
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