MARKSANS PHARMA LIMITED
Form 483 issued March 5, 2019 · Verna, India
- Observations
- 8
- Pages
- 5
- FEI number
- 3006230648
In short: On March 5, 2019, FDA issued a Form 483 with 8 observations to MARKSANS PHARMA LIMITED in Verna, Goa (FEI 3006230648). Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Laboratory controls and quality system account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
21 CFR 211.22(a) The quality control unit lacks responsibility for approving or rejecting drug products packed…
- 02
21 CFR 314.70(b)(2)(vi) Your firm did not submit a supplement submission and approval prior to distribution…
- 03
21 CFR 211.166(a)(4) The written stability program does not assure testing of the drug product in…
- 04
21 CFR 211.192 There is a failure to thoroughly review any unexplained discrepancy and the failure…
This inspection in context
Questions about this 483
What did FDA find at MARKSANS PHARMA LIMITED?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
When was MARKSANS PHARMA LIMITED inspected by FDA?
This Form 483 is dated March 5, 2019.
How do I get the full Form 483 for MARKSANS PHARMA LIMITED?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.