Homeocare Laboratories
Form 483 issued December 13, 2019 · Yonkers, New York
- Inspection
- Dec 2 – Dec 13, 2019
- Investigator
- Anastasia M. Shields
- Observations
- 6
- Pages
- 7
- FEI number
- 3008420443
In short: On December 13, 2019, FDA issued a Form 483 with 6 observations to Homeocare Laboratories in Yonkers, New York (FEI 3008420443) after an inspection that ran Dec 2 – Dec 13, 2019. The investigator was Anastasia M. Shields. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Laboratory controls and production account for 4 of 6 observations.
Most cited: 21 CFR 211.166 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
There is no written assessment of stability of homeopathic drug products based at least on testing…
- 04
The written stability testing…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Homeocare Laboratories?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Homeocare Laboratories?
Anastasia M. Shields is named on this Form 483, for the inspection of Dec 2 – Dec 13, 2019. Each investigator has a profile showing what they cite most.
When was Homeocare Laboratories inspected by FDA?
The inspection ran Dec 2 – Dec 13, 2019, and the Form 483 is dated December 13, 2019.
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.