Apitoria Pharma Private Limited
Form 483 issued May 19, 2023 · Anakapalli, India
- Inspection
- May 15 – May 19, 2023
- Investigator
- Junho Pak
- Observations
- 4
- Pages
- 4
- FEI number
- 3014477031
In short: On May 19, 2023, FDA issued a Form 483 with 4 observations to Apitoria Pharma Private Limited in Anakapalli, Andhra Pradesh (FEI 3014477031) after an inspection that ran May 15 – May 19, 2023. The investigator was Junho Pak. Most observations concern materials and facilities & equipment; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
Materials and facilities & equipment account for 3 of 4 observations.
Most cited: 21 CFR 211.80 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Manufacturing equipment cleaning and…
- 02
API product™” are not re-sealed to original conditions after…
- 03
Raw materials stored in the ambient warehouse are not stored at the specified storage conditions listed…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specification, designed to assure…
This inspection in context
Junho Pak
28 documents · 2012–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmApitoria Pharma Private Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Apitoria Pharma Private Limited?
FDA listed 4 observations on this Form 483, mostly about materials, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
Who inspected Apitoria Pharma Private Limited?
Junho Pak is named on this Form 483, for the inspection of May 15 – May 19, 2023. Each investigator has a profile showing what they cite most.
When was Apitoria Pharma Private Limited inspected by FDA?
The inspection ran May 15 – May 19, 2023, and the Form 483 is dated May 19, 2023.
How do I get the full Form 483 for Apitoria Pharma Private Limited?
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