FDA Intel

Haifa Smoked Fish, Inc.

Form 483 issued July 5, 2006 · Jamaica, New York

Inspection
Jun 20 – Jul 5, 2006
Investigators
Chasse K. Green· Joyce A. Williams· Michael R. Dominick
Observations
8
Pages
7
FEI number
3003189885

In short: On July 5, 2006, FDA issued a Form 483 with 8 observations to Haifa Smoked Fish, Inc. in Jamaica, New York (FEI 3003189885) after an inspection that ran Jun 20 – Jul 5, 2006. The investigators were Chasse K. Green, Joyce A. Williams, Michael R. Dominick and Patty P. Kaewussdangkul. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 123.6 (hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan).

At a glance

Observations span 1 system, led by food cgmp / preventive controls.

Food CGMP / preventive controls1
Other7

Most cited: 21 CFR 123.6 (4×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01
    21 CFR 123.6

    You did not implement the monitoring, recordkeeping, and verification procedures listed…

  2. 02
    21 CFR 123.7

    You did not take corrective action that ensured affected product was not entered into commerce and…

  3. 03
    21 CFR 123.6

    You do not have a written HACCP plan that outlines controls for a food safety hazard…

  4. 04
    21 CFR 123.9

    Your records do not include the name and location of the processor or importer and signature…

4 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Chasse K. Green

1 document · 2006

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 firm

Haifa Smoked Fish, Inc. history

All 11 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 123.6

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Haifa Smoked Fish, Inc.?

FDA listed 8 observations on this Form 483, mostly about food CGMP / preventive controls. 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.?

Chasse K. Green, Joyce A. Williams, Michael R. Dominick and Patty P. Kaewussdangkul are named on this Form 483, for the inspection of Jun 20 – Jul 5, 2006. Each investigator has a profile showing what they cite most.

When was Haifa Smoked Fish, Inc. inspected by FDA?

The inspection ran Jun 20 – Jul 5, 2006, and the Form 483 is dated July 5, 2006.

How do I get the full Form 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.

$99Get it free