Homeocare Laboratories
Form 483 issued June 4, 2021 · Yonkers, New York
- Inspection
- May 25 – Jun 4, 2021
- Investigator
- Tanya R. Syffrard
- Observations
- 9
- Pages
- 10
- FEI number
- 3008420443
In short: On June 4, 2021, FDA issued a Form 483 with 9 observations to Homeocare Laboratories in Yonkers, New York (FEI 3008420443) after an inspection that ran May 25 – Jun 4, 2021. The investigator was Tanya R. Syffrard. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
There is no written assessment of stability of homeopathic drug products based at least on testing…
- 03
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Tanya R. Syffrard
11 documents · 2021–2025
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in New York.
The firmHomeocare Laboratories history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Homeocare Laboratories?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Homeocare Laboratories?
Tanya R. Syffrard is named on this Form 483, for the inspection of May 25 – Jun 4, 2021. Each investigator has a profile showing what they cite most.
When was Homeocare Laboratories inspected by FDA?
The inspection ran May 25 – Jun 4, 2021, and the Form 483 is dated June 4, 2021.
How do I get the full Form 483 for Homeocare Laboratories?
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.