Homeocare Laboratories
Form 483 issued March 20, 2024 · Yonkers, New York
- Inspection
- Feb 12 – Mar 20, 2024
- Investigators
- Erik W. Koester· Jonathan G. Matrisciano
- Observations
- 12
- Pages
- 12
- FEI number
- 3008420443
In short: On March 20, 2024, FDA issued a Form 483 with 12 observations to Homeocare Laboratories in Yonkers, New York (FEI 3008420443) after an inspection that ran Feb 12 – Mar 20, 2024. The investigators were Erik W. Koester and Jonathan G. Matrisciano. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Production and facilities & equipment account for 8 of 12 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
This inspection in context
Erik W. Koester
40 documents · 2006–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Massachusetts.
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 12 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Homeocare Laboratories?
Erik W. Koester and Jonathan G. Matrisciano are named on this Form 483, for the inspection of Feb 12 – Mar 20, 2024. Each investigator has a profile showing what they cite most.
When was Homeocare Laboratories inspected by FDA?
The inspection ran Feb 12 – Mar 20, 2024, and the Form 483 is dated March 20, 2024.
How do I get the full Form 483 for Homeocare Laboratories?
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