Home Care Pharmacy of Palm Coast Inc.

Form 483 issued April 25, 2018 · Palm Coast, Florida

Inspection
Apr 23 – Apr 25, 2018
Observations
3
Pages
2
FEI number
3006899675

In short: On April 25, 2018, FDA issued a Form 483 with 3 observations to Home Care Pharmacy of Palm Coast Inc. in Palm Coast, Florida (FEI 3006899675) after an inspection that ran Apr 23 – Apr 25, 2018. The investigator was Jennifer L. Huntington.

What FDA observed

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

    You produced hazardous drugs without providing adequate containment, segregation and cleaning of work…

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

    You produced beta-lactam drugs without providing adequate containment, segregation and cleaning of work…

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

    You used a non-pharmaceutical grade component in the formulation…

The full 483

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

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This inspection in context

Questions about this 483

What did FDA find at Home Care Pharmacy of Palm Coast Inc.?

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

Who inspected Home Care Pharmacy of Palm Coast Inc.?

Jennifer L. Huntington is named on this Form 483, for the inspection of Apr 23 – Apr 25, 2018. Each investigator has a profile showing what they cite most.

When was Home Care Pharmacy of Palm Coast Inc. inspected by FDA?

The inspection ran Apr 23 – Apr 25, 2018, and the Form 483 is dated April 25, 2018.

How do I get the full Form 483 for Home Care Pharmacy of Palm Coast 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.

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