Health Pharma USA LLC
Form 483 issued December 20, 2022 · Rahway, New Jersey
- Inspection
- Dec 12 – Dec 20, 2022
- Investigators
- Nicholas Violand· Rose Jean-Mary· Syeda N. Mahazabin
- Observations
- 14
- Pages
- 12
- FEI number
- 3013856804
In short: On December 20, 2022, FDA issued a Form 483 with 14 observations to Health Pharma USA LLC in Rahway, New Jersey (FEI 3013856804) after an inspection that ran Dec 12 – Dec 20, 2022. The investigators were Nicholas Violand, Rose Jean-Mary and Syeda N. Mahazabin. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and production account for 9 of 14 observations.
Most cited: 21 CFR 211.68(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 02
The written stability testing…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Failure to maintain a backup file of data entered into the…
This inspection in context
Nicholas Violand
17 documents · 2013–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New Jersey.
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 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Health Pharma USA LLC?
FDA listed 14 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Health Pharma USA LLC?
Nicholas Violand, Rose Jean-Mary and Syeda N. Mahazabin are named on this Form 483, for the inspection of Dec 12 – Dec 20, 2022. Each investigator has a profile showing what they cite most.
When was Health Pharma USA LLC inspected by FDA?
The inspection ran Dec 12 – Dec 20, 2022, and the Form 483 is dated December 20, 2022.
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.