Jacobs Pills, Inc. d/b/a The Healthy Choice Apothecary
Form 483 issued September 24, 2020 · Elmsford, New York
- Inspection
- Sep 17 – Sep 24, 2020
- Investigator
- Mindy M. Chou
- Observations
- 3
- Pages
- 3
- FEI number
- 3013118095
In short: On September 24, 2020, FDA issued a Form 483 with 3 observations to Jacobs Pills, Inc. d/b/a The Healthy Choice Apothecary in Elmsford, New York (FEI 3013118095) after an inspection that ran Sep 17 – Sep 24, 2020. The investigator was Mindy M. Chou. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Observations span 1 system, led by laboratory controls.
Most cited: FDCA 501(a)(2)(A) (2×) · 211.165 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01FDCA 501(a)(2)(A)
You produced hazardous drugs without providing adequate segregation, cleaning of work surfaces and cleaning of…
- 02FDCA 501(a)(2)(A)
You used a non-pharmaceutical grade component in the formulation of a…
- 03
Your firm released drug product in which the strength differs from, or its purity or quality…
This inspection in context
Mindy M. Chou
37 documents · 2015–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New York.
The firmJacobs Pills, Inc. d/b/a The Healthy Choice Apothecary history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jacobs Pills, Inc. d/b/a The Healthy Choice Apothecary?
FDA listed 3 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Jacobs Pills, Inc. d/b/a The Healthy Choice Apothecary?
Mindy M. Chou is named on this Form 483, for the inspection of Sep 17 – Sep 24, 2020. Each investigator has a profile showing what they cite most.
When was Jacobs Pills, Inc. d/b/a The Healthy Choice Apothecary inspected by FDA?
The inspection ran Sep 17 – Sep 24, 2020, and the Form 483 is dated September 24, 2020.
How do I get the full Form 483 for Jacobs Pills, Inc. d/b/a The Healthy Choice Apothecary?
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.