Haifa Smoked Fish, Inc.
Amended 483 issued October 7, 2005 · Jamaica, New York
- Inspection
- Sep 13 – Oct 7, 2005
- Investigators
- Andrew F. Cohen· Charisse K. Green· Joyce A. Williams
- Observations
- 7
- Pages
- 14
- FEI number
- 3003189885
In short: On October 7, 2005, FDA issued a Amended 483 with 7 observations to Haifa Smoked Fish, Inc. in Jamaica, New York (FEI 3003189885) after an inspection that ran Sep 13 – Oct 7, 2005. The investigators were Andrew F. Cohen, Charisse K. Green, Joyce A. Williams and Michael R. Dominick. The most-cited regulation is 21 CFR 123.6 (hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan).
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
You did not take cOITective action that ensured affected product was not entered into commerce and…
- 03
Your review of critical conTrol poinr monitoring records does not ensure that the records arc complete…
- 04
Your H.."",-CCP plan does not liST verification procedures and frequencies rhat have been developed to ensure…
3 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Andrew F. Cohen
7 documents · 2001–2009
Cites 123.6 (hazard analysis and hazard analysis critical control point (haccp) plan) more than any other section. Most of their documents are for sites in New York.
The firmHaifa Smoked Fish, Inc. history
All 11 documents on file for this site, in date order, with what was cited at each inspection.
Similar documentsOther sites cited under 123.6
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Haifa Smoked Fish, Inc.?
FDA listed 7 observations on this Form 483. The most-cited regulation is 21 CFR 123.6 (hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan). The opening words of each observation are shown on this page.
Who inspected Haifa Smoked Fish, Inc.?
Andrew F. Cohen, Charisse K. Green, Joyce A. Williams and Michael R. Dominick are named on this Amended 483, for the inspection of Sep 13 – Oct 7, 2005. Each investigator has a profile showing what they cite most.
When was Haifa Smoked Fish, Inc. inspected by FDA?
The inspection ran Sep 13 – Oct 7, 2005, and the Amended 483 is dated October 7, 2005.
How do I get the full Amended 483 for Haifa Smoked Fish, Inc.?
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.