Apex Healthcare Limited
Form 483 issued June 15, 2023 · Ankleshwar, India
- Inspection
- Jun 12 – Jun 15, 2023
- Investigator
- Gavin T. Cua
- Observations
- 3
- Pages
- 2
- FEI number
- 3006509185
In short: On June 15, 2023, FDA issued a Form 483 with 3 observations to Apex Healthcare Limited in Ankleshwar, Gujarat (FEI 3006509185) after an inspection that ran Jun 12 – Jun 15, 2023. The investigator was Gavin T. Cua. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The firm's written procedure for the review of laboratory…
- 02
Computerized systems do not have adequate controls to prevent…
- 03
The firm does not have an established…
This inspection in context
Gavin T. Cua
9 documents · 2022–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmApex Healthcare Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Apex Healthcare Limited?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, facilities & equipment and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Apex Healthcare Limited?
Gavin T. Cua is named on this Form 483, for the inspection of Jun 12 – Jun 15, 2023. Each investigator has a profile showing what they cite most.
When was Apex Healthcare Limited inspected by FDA?
The inspection ran Jun 12 – Jun 15, 2023, and the Form 483 is dated June 15, 2023.
How do I get the full Form 483 for Apex 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.