East Marietta Drug Company

Form 483 issued August 23, 2019 · Marietta, Georgia

Inspection
Aug 19 – Aug 23, 2019
Observations
3
Pages
2
FEI number
3012263025

In short: On August 23, 2019, FDA issued a Form 483 with 3 observations to East Marietta Drug Company in Marietta, Georgia (FEI 3012263025) after an inspection that ran Aug 19 – Aug 23, 2019. The investigators were Gideon N. Esuzor and Johnetta F. Walters.

What FDA observed

Preview: the opening words of each observation
  1. 01
    FDCA 501(a)(2)(A)

    You produced highly potent drugs without providing adequate cleaning of work…

  2. 02
    FDCA 501(a)(2)(A)

    Personnel did not disinfect and change gloves frequently…

  3. 03
    FDCA 501(a)(2)(A)

    Non-microbial contamination was observed in…

The full 483

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This inspection in context

Questions about this 483

What did FDA find at East Marietta Drug Company?

FDA listed 3 observations on this Form 483. The opening words of each observation are shown on this page.

Who inspected East Marietta Drug Company?

Gideon N. Esuzor and Johnetta F. Walters are named on this Form 483, for the inspection of Aug 19 – Aug 23, 2019. Each investigator has a profile showing what they cite most.

When was East Marietta Drug Company inspected by FDA?

The inspection ran Aug 19 – Aug 23, 2019, and the Form 483 is dated August 23, 2019.

How do I get the full Form 483 for East Marietta Drug Company?

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