FDA Intel

Quality Formulation Laboratories, Inc.

Form 483 issued January 13, 2009 · Paterson, New Jersey

Inspection
Jan 13, 2009
Investigators
Kerry A. Donovan· Valerie C. Reed
Observations
17
Pages
8
FEI number
2243677

In short: On January 13, 2009, FDA issued a Form 483 with 17 observations to Quality Formulation Laboratories, Inc. in Paterson, New Jersey (FEI 2243677) after an inspection that ran Jan 13, 2009. The investigators were Kerry A. Donovan and Valerie C. Reed. Most observations concern dietary supplement CGMP; the most-cited regulation is 21 CFR 111.15 (what sanitation requirements apply to your physical plant and grounds?).

At a glance

17 of 17 observations on this 483 concern dietary supplement cgmp.

Dietary supplement CGMP17

Most cited: 21 CFR 111.15 (15×) · 111.455 (3×)

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 111.15

    Apparent REP's, too numerous to count, concentrated on two spots, the upper left hand corner approximately…

  2. 02
    21 CFR 111.455

    On 12111/2008, upon examination of five bags of Alkalized Cocoa with Lecithin, lot number 3028 11013…

  3. 03
    21 CFR 111.455

    Observation 3: scanned text, readable in the full document.

  4. 04
    21 CFR 111.15

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

13 more observations

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

Get the full 483

This inspection in context

The investigator

Kerry A. Donovan

1 document · 2009

Cites 111.15 (what sanitation requirements apply to your physical plant and grounds?) more than any other section. Most of their documents are for sites in New Jersey.

The firm

Quality Formulation Laboratories, Inc. history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 111.15

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Quality Formulation Laboratories, Inc.?

FDA listed 17 observations on this Form 483, mostly about dietary supplement CGMP. The most-cited regulation is 21 CFR 111.15 (what sanitation requirements apply to your physical plant and grounds?). The opening words of each observation are shown on this page.

Who inspected Quality Formulation Laboratories, Inc.?

Kerry A. Donovan and Valerie C. Reed are named on this Form 483, for the inspection of Jan 13, 2009. Each investigator has a profile showing what they cite most.

When was Quality Formulation Laboratories, Inc. inspected by FDA?

The inspection ran Jan 13, 2009, and the Form 483 is dated January 13, 2009.

How do I get the full Form 483 for Quality Formulation Laboratories, 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