Aspiro Pharma Limited
Form 483 issued October 7, 2021 · Siddipet, India
- Inspection
- Sep 27 – Oct 7, 2021
- Investigator
- Kellia N. Hicks
- Observations
- 2
- Pages
- 6
- FEI number
- 3014483338
In short: On October 7, 2021, FDA issued a Form 483 with 2 observations to Aspiro Pharma Limited in Siddipet, Telangana (FEI 3014483338) after an inspection that ran Sep 27 – Oct 7, 2021. The investigator was Kellia N. Hicks. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Deviations from written production and process control procedures are not recorded…
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 firmAspiro Pharma 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 Aspiro Pharma Limited?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Aspiro Pharma Limited?
Kellia N. Hicks is named on this Form 483, for the inspection of Sep 27 – Oct 7, 2021. Each investigator has a profile showing what they cite most.
When was Aspiro Pharma Limited inspected by FDA?
The inspection ran Sep 27 – Oct 7, 2021, and the Form 483 is dated October 7, 2021.
How do I get the full Form 483 for Aspiro Pharma 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.