AXXELENT PHARMA SCIENCE PRIVATE LIMITED
Form 483 issued June 21, 2024 · Sri City, India
- Inspection
- Jun 17 – Jun 21, 2024
- Investigator
- Paranthaman Senthamaraikannan
- Observations
- 4
- Pages
- 4
- FEI number
- 3026504936
In short: On June 21, 2024, FDA issued a Form 483 with 4 observations to AXXELENT PHARMA SCIENCE PRIVATE LIMITED in Sri City, Andhra Pradesh (FEI 3026504936) after an inspection that ran Jun 17 – Jun 21, 2024. The investigator was Paranthaman Senthamaraikannan. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 02
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 03
Employees are not given training in…
- 04
Laboratory records do not include the initials or signature of the person who performs each test…
This inspection in context
Paranthaman Senthamaraikannan
6 documents · 2022–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Ohio.
The firmAXXELENT PHARMA SCIENCE PRIVATE LIMITED history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AXXELENT PHARMA SCIENCE PRIVATE LIMITED?
FDA listed 4 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected AXXELENT PHARMA SCIENCE PRIVATE LIMITED?
Paranthaman Senthamaraikannan is named on this Form 483, for the inspection of Jun 17 – Jun 21, 2024. Each investigator has a profile showing what they cite most.
When was AXXELENT PHARMA SCIENCE PRIVATE LIMITED inspected by FDA?
The inspection ran Jun 17 – Jun 21, 2024, and the Form 483 is dated June 21, 2024.
How do I get the full Form 483 for AXXELENT PHARMA SCIENCE PRIVATE LIMITED?
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