MARKSANS PHARMA LIMITED
Form 483 issued August 4, 2023 · Verna, India
- Inspection
- Jul 31 – Aug 4, 2023
- Observations
- 2
- Pages
- 2
- FEI number
- 3006230648
In short: On August 4, 2023, FDA issued a Form 483 with 2 observations to MARKSANS PHARMA LIMITED in Verna, Goa (FEI 3006230648) after an inspection that ran Jul 31 – Aug 4, 2023. The most-cited regulation is 21 CFR 310.305 (records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications).
What FDA observed
Preview: the opening words of each observation- 01
Adverse drug experience information has not…
- 02
Written procedures have not been developed for the surveillance, receipt, evaluation and reporting to FDA of…
This inspection in context
Questions about this 483
What did FDA find at MARKSANS PHARMA LIMITED?
FDA listed 2 observations on this Form 483. The most-cited regulation is 21 CFR 310.305 (records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications). The opening words of each observation are shown on this page.
When was MARKSANS PHARMA LIMITED inspected by FDA?
The inspection ran Jul 31 – Aug 4, 2023, and the Form 483 is dated August 4, 2023.
How do I get the full Form 483 for MARKSANS PHARMA LIMITED?
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