Apitoria Pharma Private Limited
Form 483 issued October 25, 2019 · Jinnaram Mandal, India
- Inspection
- Oct 21 – Oct 25, 2019
- Investigators
- Gayle S. Lawson· Kenneth H. Williams
- Observations
- 3
- Pages
- 2
- FEI number
- 3004086884
In short: On October 25, 2019, FDA issued a Form 483 with 3 observations to Apitoria Pharma Private Limited in Jinnaram Mandal, India (FEI 3004086884) after an inspection that ran Oct 21 – Oct 25, 2019. The investigators were Gayle S. Lawson and Kenneth H. Williams. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 2 of 3 observations.
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 established to assure that equipment is clean prior to use, where full…
- 03
(The responsibilities and procedures applicable to the Quality Unit are not established or fully followed. pecifically…
- 04
Batch production and control records do not always include complete information and data relating to the…
This inspection in context
Gayle S. Lawson
10 documents · 2015–2019
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmApitoria Pharma Private Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Apitoria Pharma Private Limited?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Apitoria Pharma Private Limited?
Gayle S. Lawson and Kenneth H. Williams are named on this Form 483, for the inspection of Oct 21 – Oct 25, 2019. Each investigator has a profile showing what they cite most.
When was Apitoria Pharma Private Limited inspected by FDA?
The inspection ran Oct 21 – Oct 25, 2019, and the Form 483 is dated October 25, 2019.
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.