Homeocare Laboratories
Form 483 issued February 21, 2023 · Yonkers, New York
- Inspection
- Jan 30 – Feb 21, 2023
- Investigators
- Raihan A. Chowdhury· Terry Bridgewater· Vivin George
- Observations
- 10
- Pages
- 11
- FEI number
- 3008420443
In short: On February 21, 2023, FDA issued a Form 483 with 10 observations to Homeocare Laboratories in Yonkers, New York (FEI 3008420443) after an inspection that ran Jan 30 – Feb 21, 2023. The investigators were Raihan A. Chowdhury, Terry Bridgewater and Vivin George. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
There is no written assessment of stability of homeopathic drug products based at least on testing…
- 04
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and…
This inspection in context
Raihan A. Chowdhury
4 documents · 2023–2025
Cites 211.188(b)(2) (batch production and control records) 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 10 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Homeocare Laboratories?
Raihan A. Chowdhury, Terry Bridgewater and Vivin George are named on this Form 483, for the inspection of Jan 30 – Feb 21, 2023. Each investigator has a profile showing what they cite most.
When was Homeocare Laboratories inspected by FDA?
The inspection ran Jan 30 – Feb 21, 2023, and the Form 483 is dated February 21, 2023.
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.