Lifetime Value Pharmacy III Inc.

Form 483 issued February 21, 2019 · Santa Ana, California

Inspection
Jan 10 – Feb 21, 2019
Observations
9
Pages
5
FEI number
3014857565

In short: On February 21, 2019, FDA issued a Form 483 with 9 observations to Lifetime Value Pharmacy III Inc. in Santa Ana, California (FEI 3014857565) after an inspection that ran Jan 10 – Feb 21, 2019. The investigator was Christopher R. Czajka.

What FDA observed

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

    You did not make adequate product evaluation and take remedial action where actionable microbial contamination was…

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

    Personnel did not disinfect and change gloves frequently…

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

    You did not make adequate product evaluation and take remedial action where actionable microbial contamination was…

  4. 04
    FDCA 501(a)(2)(A)

    The ISO 5 classified aseptic processing areas had difficult to clean, particle-generating and visibly…

5 more observations

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

Get the full 483

This inspection in context

Questions about this 483

What did FDA find at Lifetime Value Pharmacy III Inc.?

FDA listed 9 observations on this Form 483. The opening words of each observation are shown on this page.

Who inspected Lifetime Value Pharmacy III Inc.?

Christopher R. Czajka is named on this Form 483, for the inspection of Jan 10 – Feb 21, 2019. Each investigator has a profile showing what they cite most.

When was Lifetime Value Pharmacy III Inc. inspected by FDA?

The inspection ran Jan 10 – Feb 21, 2019, and the Form 483 is dated February 21, 2019.

How do I get the full Form 483 for Lifetime Value Pharmacy III 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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