Jacobs Pills, Inc. d/b/a The Healthy Choice Apothecary
Form 483 issued February 28, 2017 · Elmsford, New York
- Inspection
- Feb 22 – Feb 24, 2020
- Investigator
- Mindy M. Chou
- Observations
- 1
- Pages
- 1
- FEI number
- 3013118095
In short: On February 28, 2017, FDA issued a Form 483 with 1 observation to Jacobs Pills, Inc. d/b/a The Healthy Choice Apothecary in Elmsford, New York (FEI 3013118095) after an inspection that ran Feb 22 – Feb 24, 2020. The investigator was Mindy M. Chou. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
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 211.192
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 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). 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 Feb 22 – Feb 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 Feb 22 – Feb 24, 2020, and the Form 483 is dated February 28, 2017.
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.