Aktinos Pharma Private Limited
Form 483 issued November 1, 2018 · Visakhapatnam, India
- Inspection
- Oct 29 – Nov 1, 2018
- Investigator
- Kellia N. Hicks
- Observations
- 6
- Pages
- 4
- FEI number
- 3012575874
In short: On November 1, 2018, FDA issued a Form 483 with 6 observations to Aktinos Pharma Private Limited in Visakhapatnam, Andhra Pradesh (FEI 3012575874) after an inspection that ran Oct 29 – Nov 1, 2018. The investigator was Kellia N. Hicks. Most observations concern quality system and production.
At a glance
Quality system and production account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A + (b) (4), used for…
- 02
The accuracy, sensitivity, specificity, and reproducibility of analytical methods have not been established and documented to…
- 03
Equipment and utensils are not cleaned, maintained, and, as appropriate for the nature of the drug…
- 04
Investigations are not thoroughly documented or investigated. 7…
This inspection in context
Kellia N. Hicks
28 documents · 2017–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmAktinos Pharma Private Limited history
The site's inspection history, in date order.
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 Aktinos Pharma Private Limited?
FDA listed 6 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Aktinos Pharma Private Limited?
Kellia N. Hicks is named on this Form 483, for the inspection of Oct 29 – Nov 1, 2018. Each investigator has a profile showing what they cite most.
When was Aktinos Pharma Private Limited inspected by FDA?
The inspection ran Oct 29 – Nov 1, 2018, and the Form 483 is dated November 1, 2018.
How do I get the full Form 483 for Aktinos 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.