Apitoria Pharma Private Limited
Form 483 issued July 1, 2016
- Observations
- 1
- Pages
- 1
- FEI number
- 3004086884
In short: On July 1, 2016, FDA issued a Form 483 with 1 observation to Apitoria Pharma Private Limited (FEI 3004086884). Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations are…
This inspection in context
Questions about this 483
What did FDA find at Apitoria Pharma Private Limited?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Apitoria Pharma Private Limited inspected by FDA?
This Form 483 is dated July 1, 2016.
How do I get the full Form 483 for Apitoria Pharma Private 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.