USFDA inspection at InvaGen facility concludes with zero Form 483 observations
USFDA conducted a routine cGMP inspection at the InvaGen Pharmaceuticals Inc. facility in Hauppauge, Long Island, New York, USA, from 19th October, 2026 to 22nd October, 2026 (ET).
By ScoutQuest · · 1 min read
- Inspection Type
- routine cGMP inspection
- Inspection Period
- 19th October, 2026 to 22nd October, 2026 (ET)
- Form 483 Observations
- zero
What was announced
Cipla has notified the stock exchanges about a United States Food and Drug Administration (USFDA) inspection at the manufacturing facility of InvaGen Pharmaceuticals Inc., a wholly owned subsidiary of the company. The site is located in Hauppauge, Long Island, New York, USA.
Inspection details
- The inspection was a routine current Good Manufacturing Practices (cGMP) inspection.
- It was conducted from 19th October, 2026 to 22nd October, 2026 (ET).
- The inspection concluded with zero Form 483 observations.
What a Form 483 is
At the end of a USFDA inspection, the agency issues a Form 483 if it has recorded conditions that, in its judgement, may indicate a violation of manufacturing or quality norms. Each such recorded item is called an observation.
Zero observations means the inspection closed without any such observations being issued to the facility.
Why investors watch USFDA inspections
- The United States is a major market for Indian pharmaceutical companies, and manufacturing sites that supply it must meet USFDA standards.
- An inspection outcome is one of the visible checkpoints on how a site is assessed for compliance with those standards.
- This disclosure covers one facility of a wholly owned subsidiary; it records the outcome of this inspection as stated by the company.
What the update states
The company has taken the above information on record and the disclosure was signed by Rajendra Chopra, Company Secretary.
Also from Cipla
Analyst discussion on freight cost pressure impacting revenue this quarter, and the Lanreotide impact on Cipla's US/North America business
16 Oct 2026
Cipla to release Q2FY27 unaudited results and host earnings conference call on 27 October 2026
13 Oct 2026
Board Meeting on 27 October 2026 for Q2 and Half-Year Results
28 Sep 2026
More numbers
- Form 483 observations at end of USFDA inspectionzero
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