Apitoria Pharma Private Limited
Form 483 issued August 2, 2022 · Srikakulam, India
- Investigator
- Weeeee Geue Guerlain Ulysse
- Observations
- 3
- Pages
- 3
- FEI number
- 3004611182
In short: On August 2, 2022, FDA issued a Form 483 with 3 observations to Apitoria Pharma Private Limited in Srikakulam, Andhra Pradesh (FEI 3004611182). The investigator was Weeeee Geue Guerlain Ulysse. Most observations concern quality system and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for the cleaning and maintenance of equipment are deficient regarding the removal or obliteration of…
- 02
There is a failure to thoroughly investigate any unexplained discrepancy whether or not the batch has…
- 03
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Weeeee Geue Guerlain Ulysse
1 document · 2022
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 211.67
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 quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Apitoria Pharma Private Limited?
Weeeee Geue Guerlain Ulysse is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Apitoria Pharma Private Limited inspected by FDA?
This Form 483 is dated August 2, 2022.
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.