Solara Active Pharma Sciences Limited
Form 483 issued July 27, 2018 · Mangaluru, India
- Observations
- 2
- Pages
- 2
- FEI number
- 3008252997
In short: On July 27, 2018, FDA issued a Form 483 with 2 observations to Solara Active Pharma Sciences Limited in Mangaluru, Karnataka (FEI 3008252997). Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.67 (1×) · 211.165 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not adequate for equipment cleaning and its subsequent release for use in the…
- 02
Method validation for forced degradation of active pharmaceutical ingredients does not ensure that the test method…
This inspection in context
Questions about this 483
What did FDA find at Solara Active Pharma Sciences Limited?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
When was Solara Active Pharma Sciences Limited inspected by FDA?
This Form 483 is dated July 27, 2018.
How do I get the full Form 483 for Solara Active Pharma Sciences 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.