OHM PHARMA INC.
Form 483 issued March 18, 2020 · Mineral Wells, Texas
- Inspection
- Feb 24 – Mar 18, 2020
- Investigators
- Khunnathee Stoner· Lisa Whitt
- Observations
- 1
- Pages
- 1
- FEI number
- 3003231743
In short: On March 18, 2020, FDA issued a Form 483 with 1 observation to OHM PHARMA INC. in Mineral Wells, Texas (FEI 3003231743) after an inspection that ran Feb 24 – Mar 18, 2020. The investigators were Khunnathee Stoner and Lisa Whitt. Most observations concern dietary supplement CGMP; the most-cited regulation is 21 CFR 111.77 (what must you do if established specifications are not met?).
At a glance
1 of 1 observations on this 483 concern dietary supplement cgmp.
Most cited: 21 CFR 111.77 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your Quality Assurance personnel approved and released for distribution a batch of dietary supplement that did…
This inspection in context
Khunnathee Stoner
1 document · 2020
Cites 111.77 (what must you do if established specifications are not met?) more than any other section. Most of their documents are for sites in Texas.
The firmOHM PHARMA 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 111.77
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at OHM PHARMA INC.?
FDA listed 1 observation on this Form 483, mostly about dietary supplement CGMP. The most-cited regulation is 21 CFR 111.77 (what must you do if established specifications are not met?). The opening words of each observation are shown on this page.
Who inspected OHM PHARMA INC.?
Khunnathee Stoner and Lisa Whitt are named on this Form 483, for the inspection of Feb 24 – Mar 18, 2020. Each investigator has a profile showing what they cite most.
When was OHM PHARMA INC. inspected by FDA?
The inspection ran Feb 24 – Mar 18, 2020, and the Form 483 is dated March 18, 2020.
How do I get the full Form 483 for OHM PHARMA 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.