FDA Intel

SM Fish Corp.

Form 483 issued September 9, 2016 · Far Rockaway, New York

Inspection
Aug 15 – Sep 9, 2016
Investigators
Christine M. Rivera· Erica B. Raphael· Raymond M. Lam
Observations
11
Pages
13
FEI number
3008734616

In short: On September 9, 2016, FDA issued a Form 483 with 11 observations to SM Fish Corp. in Far Rockaway, New York (FEI 3008734616) after an inspection that ran Aug 15 – Sep 9, 2016. The investigators were Christine M. Rivera, Erica B. Raphael and Raymond M. Lam. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 110.35 (sanitary operations).

At a glance

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

Food CGMP / preventive controls6
Other5

Most cited: 21 CFR 123.6(b) (2×) · 110.35(a) (2×)

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 123.6(b)

    You did not impl emen t the recordkeeping and verification procedures listed…

  2. 02
    21 CFR 123.6(b)

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

  3. 03
    21 CFR 123.8(a)(2)(ii)

    Your process monitoring equipment is not calibrated to ensure…

  4. 04
    21 CFR 123.11(b)

    Observation 4: scanned text, readable in the full document.

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

Christine M. Rivera

1 document · 2016

Cites 110.35(a) (sanitary operations) more than any other section. Most of their documents are for sites in New York.

The firm

SM Fish Corp. history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 123.6(b)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at SM Fish Corp.?

FDA listed 11 observations on this Form 483, mostly about food CGMP / preventive controls. The most-cited regulation is 21 CFR 110.35 (sanitary operations). The opening words of each observation are shown on this page.

Who inspected SM Fish Corp.?

Christine M. Rivera, Erica B. Raphael and Raymond M. Lam are named on this Form 483, for the inspection of Aug 15 – Sep 9, 2016. Each investigator has a profile showing what they cite most.

When was SM Fish Corp. inspected by FDA?

The inspection ran Aug 15 – Sep 9, 2016, and the Form 483 is dated September 9, 2016.

How do I get the full Form 483 for SM Fish Corp.?

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