Apitoria Pharma Private Limited
Form 483 issued September 27, 2024 · Sangareddy, India
- Inspection
- Sep 23 – Sep 27, 2024
- Investigators
- Khalid M. Khan· Pushpa Suresh
- Observations
- 10
- Pages
- 8
- FEI number
- 3004086884
In short: On September 27, 2024, FDA issued a Form 483 with 10 observations to Apitoria Pharma Private Limited in Sangareddy, Telangana (FEI 3004086884) after an inspection that ran Sep 23 – Sep 27, 2024. The investigators were Khalid M. Khan and Pushpa Suresh. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Quality system and facilities & equipment account for 7 of 10 observations.
Most cited: 21 CFR 211.67 (2×) · 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacturing of drug substances and intermediates is not of adequate upkeep to…
- 02
Failure to establish adequate manufacturing instructions in the production records for…
- 03
Failure to ensure training is regularly conducted by qualified individuals and covers, at a minimum, the…
- 04
Failure of your quality unit to review and approve…
This inspection in context
Khalid M. Khan
1 document · 2024
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
All 3 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 10 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Apitoria Pharma Private Limited?
Khalid M. Khan and Pushpa Suresh are named on this Form 483, for the inspection of Sep 23 – Sep 27, 2024. Each investigator has a profile showing what they cite most.
When was Apitoria Pharma Private Limited inspected by FDA?
The inspection ran Sep 23 – Sep 27, 2024, and the Form 483 is dated September 27, 2024.
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.