APL HEALTHCARE LIMITED
Form 483 issued September 19, 2023 · Tirupati, India
- Inspection
- Sep 13 – Sep 19, 2023
- Investigator
- Kellia N. Hicks
- Observations
- 1
- Pages
- 2
- FEI number
- 3011895410
In short: On September 19, 2023, FDA issued a Form 483 with 1 observation to APL HEALTHCARE LIMITED in Tirupati, Andhra Pradesh (FEI 3011895410) after an inspection that ran Sep 13 – Sep 19, 2023. The investigator was Kellia N. Hicks. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (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…
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 firmAPL HEALTHCARE LIMITED history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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 APL HEALTHCARE LIMITED?
FDA listed 1 observation on this Form 483, mostly about quality system. 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 APL HEALTHCARE LIMITED?
Kellia N. Hicks is named on this Form 483, for the inspection of Sep 13 – Sep 19, 2023. Each investigator has a profile showing what they cite most.
When was APL HEALTHCARE LIMITED inspected by FDA?
The inspection ran Sep 13 – Sep 19, 2023, and the Form 483 is dated September 19, 2023.
How do I get the full Form 483 for APL HEALTHCARE 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.