FDA Intel

Haifa Smoked Fish, Inc.

Form 483 issued January 31, 2001 · Jamaica, New York

Inspection
Jan 23 – Jan 31, 2001
Investigator
Andrew F. Cohen
Observations
11
Pages
1
FEI number
3003189885

In short: On January 31, 2001, FDA issued a Form 483 with 11 observations to Haifa Smoked Fish, Inc. in Jamaica, New York (FEI 3003189885) after an inspection that ran Jan 23 – Jan 31, 2001. The investigator was Andrew F. Cohen. 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 controls5
Other6

Most cited: 21 CFR 123.6 (4×) · 110.80 (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

    Firm's HACCP plan fails to recognize the significant hazard of histamine fonnation in the receiving of…

  2. 02
    21 CFR 123.6

    Firm's HACCP plan fails to recognize the significant hazard of histamine fonnation in the thawing…

  3. 03
    21 CFR 123.6

    Finn's RACCP plan fails to list various species offish covered…

  4. 04
    21 CFR 123.6

    Firm's RACCP plan recognizes under CCP #2 for thawing under the frequency of monitoring temperatures…

7 more observations

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

Get the full 483

This inspection in context

The investigator

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 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 11 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.?

Andrew F. Cohen is named on this Form 483, for the inspection of Jan 23 – Jan 31, 2001. Each investigator has a profile showing what they cite most.

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

The inspection ran Jan 23 – Jan 31, 2001, and the Form 483 is dated January 31, 2001.

How do I get the full Form 483 for Haifa Smoked Fish, Inc.?

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