NuCare Pharmaceuticals, Inc.
Form 483 issued January 10, 2020 · ORANGE, California
- Inspection
- Jan 9 – Jan 10, 2020
- Investigator
- Rumany C. Penn
- Observations
- 1
- Pages
- 1
- FEI number
- 3003294404
In short: On January 10, 2020, FDA issued a Form 483 with 1 observation to NuCare Pharmaceuticals, Inc. in ORANGE, California (FEI 3003294404) after an inspection that ran Jan 9 – Jan 10, 2020. The investigator was Rumany C. Penn. Most observations concern packaging & labeling; the most-cited regulation is 21 CFR 211.137 (expiration dating).
At a glance
1 of 1 observations on this 483 concern packaging & labeling.
Most cited: 21 CFR 211.137(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
This inspection in context
Rumany C. Penn
21 documents · 2016–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmNuCare Pharmaceuticals, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.137(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at NuCare Pharmaceuticals, Inc.?
FDA listed 1 observation on this Form 483, mostly about packaging & labeling. The most-cited regulation is 21 CFR 211.137 (expiration dating). The opening words of each observation are shown on this page.
Who inspected NuCare Pharmaceuticals, Inc.?
Rumany C. Penn is named on this Form 483, for the inspection of Jan 9 – Jan 10, 2020. Each investigator has a profile showing what they cite most.
When was NuCare Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Jan 9 – Jan 10, 2020, and the Form 483 is dated January 10, 2020.
How do I get the full Form 483 for NuCare Pharmaceuticals, Inc.?
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.