Apitoria Pharma Private Limited
Form 483 issued February 9, 2019 · Srikakulam, India
- Inspection
- Feb 4 – Feb 9, 2019
- Investigator
- Dipesh K. Shah
- Observations
- 3
- Pages
- 4
- FEI number
- 3004611182
In short: On February 9, 2019, FDA issued a Form 483 with 3 observations to Apitoria Pharma Private Limited in Srikakulam, Andhra Pradesh (FEI 3004611182) after an inspection that ran Feb 4 – Feb 9, 2019. The investigator was Dipesh K. Shah. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls 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
Laboratory controls fails to include the establishment of scientifically sound and appropriate specifications, and test procedures…
- 02
Investigations are inadequate in that they do not evaluate…
- 03
Master production batch records are inadequate for…
This inspection in context
Dipesh K. Shah
29 documents · 2006–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmApitoria Pharma Private Limited history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
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 laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Apitoria Pharma Private Limited?
Dipesh K. Shah is named on this Form 483, for the inspection of Feb 4 – Feb 9, 2019. Each investigator has a profile showing what they cite most.
When was Apitoria Pharma Private Limited inspected by FDA?
The inspection ran Feb 4 – Feb 9, 2019, and the Form 483 is dated February 9, 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.