Ronald Maurer

Form 483 issued February 17, 2011 · Klingerstown, Pennsylvania

Inspection
Feb 17, 2011
Observations
3
Pages
1
FEI number
3008775781

In short: On February 17, 2011, FDA issued a Form 483 with 3 observations to Ronald Maurer in Klingerstown, Pennsylvania (FEI 3008775781) after an inspection that ran Feb 17, 2011. The investigators were Bradley E. Benasutti, Brandi L. Garbutt and John M. Mastalski. The most-cited regulation is 21 CFR 118.10 (recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan).

What FDA observed

Preview: the opening words of each observation
  1. 01

    All your required records do not include the time of the activity…

  2. 02

    All required records do not have the signature or initials of the person performing the operation…

  3. 03

    Your written SE plan does not bear a date and carry the signature(s) and not the…

The full 483

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This inspection in context

Questions about this 483

What did FDA find at Ronald Maurer?

FDA listed 3 observations on this Form 483. The most-cited regulation is 21 CFR 118.10 (recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan). The opening words of each observation are shown on this page.

Who inspected Ronald Maurer?

Bradley E. Benasutti, Brandi L. Garbutt and John M. Mastalski are named on this Form 483, for the inspection of Feb 17, 2011. Each investigator has a profile showing what they cite most.

When was Ronald Maurer inspected by FDA?

The inspection ran Feb 17, 2011, and the Form 483 is dated February 17, 2011.

How do I get the full Form 483 for Ronald Maurer?

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