Health Pharma USA LLC
Form 483 issued July 3, 2024 · Rahway, New Jersey
- Inspection
- Jun 17 – Jul 3, 2024
- Investigators
- Andrew O. Ejiofor· Annet R. Rajan· Suchan Kim
- Observations
- 7
- Pages
- 15
- FEI number
- 3013856804
In short: On July 3, 2024, FDA issued a Form 483 with 7 observations to Health Pharma USA LLC in Rahway, New Jersey (FEI 3013856804) after an inspection that ran Jun 17 – Jul 3, 2024. The investigators were Andrew O. Ejiofor, Annet R. Rajan and Suchan Kim. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Equipment used in the manufacture, processing, packing or holding of ding products is not of appropriate…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 04
The written stability program for drug products does not include reliable, meaningful…
This inspection in context
Andrew O. Ejiofor
5 documents · 2024–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Georgia.
The firmHealth Pharma USA LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Health Pharma USA LLC?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Health Pharma USA LLC?
Andrew O. Ejiofor, Annet R. Rajan and Suchan Kim are named on this Form 483, for the inspection of Jun 17 – Jul 3, 2024. Each investigator has a profile showing what they cite most.
When was Health Pharma USA LLC inspected by FDA?
The inspection ran Jun 17 – Jul 3, 2024, and the Form 483 is dated July 3, 2024.
How do I get the full Form 483 for Health Pharma USA LLC?
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.