FDA Intel

First Pharma Associates LLC

Form 483 issued June 7, 2019 · Spokane, Washington

Inspection
Jun 3, 2019 – Jun 7, 2020
Investigators
Jeffrey P. Raimondi· Linda F. Murphy
Observations
10
Pages
5
FEI number
3007500366

In short: On June 7, 2019, FDA issued a Form 483 with 10 observations to First Pharma Associates LLC in Spokane, Washington (FEI 3007500366) after an inspection that ran Jun 3, 2019 – Jun 7, 2020. The investigators were Jeffrey P. Raimondi and Linda F. Murphy. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

7 of 10 observations on this 483 concern facilities & equipment.

Facilities & equipment7
Production3

Most cited: 21 CFR 211.42 (6×) · 211.113 (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 211.56

    Non-microbial contamination was observed…

  2. 02
    21 CFR 211.113

    Personnel were observed manually contacting the inner surface of…

  3. 03
    21 CFR 211.42

    Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or…

  4. 04
    21 CFR 211.42

    ISO-5 classified areas were not…

6 more observations

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

Get the full 483

This inspection in context

The investigator

Jeffrey P. Raimondi

40 documents · 2017–2026

Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.

The firm

First Pharma Associates LLC history

All 5 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.42

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at First Pharma Associates LLC?

FDA listed 10 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.

Who inspected First Pharma Associates LLC?

Jeffrey P. Raimondi and Linda F. Murphy are named on this Form 483, for the inspection of Jun 3, 2019 – Jun 7, 2020. Each investigator has a profile showing what they cite most.

When was First Pharma Associates LLC inspected by FDA?

The inspection ran Jun 3, 2019 – Jun 7, 2020, and the Form 483 is dated June 7, 2019.

How do I get the full Form 483 for First Pharma Associates LLC?

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