Good Health, Inc. DBA Premier Pharmacy Services
Form 483 issued November 29, 2018 · Baldwin Park, California
- Inspection
- Nov 8 – Nov 16, 2018
- Investigator
- Joey V. Quitania
- Observations
- 2
- Pages
- 2
- FEI number
- 3014549940
In short: On November 29, 2018, FDA issued a Form 483 with 2 observations to Good Health, Inc. DBA Premier Pharmacy Services in Baldwin Park, California (FEI 3014549940) after an inspection that ran Nov 8 – Nov 16, 2018. The investigator was Joey V. Quitania. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.42 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You produced beta-lactam drugs without providing adequate cleaning of work surfaces…
- 02
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was…
This inspection in context
Joey V. Quitania
23 documents · 2009–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmGood Health, Inc. DBA Premier Pharmacy Services history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Good Health, Inc. DBA Premier Pharmacy Services?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. 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 Good Health, Inc. DBA Premier Pharmacy Services?
Joey V. Quitania is named on this Form 483, for the inspection of Nov 8 – Nov 16, 2018. Each investigator has a profile showing what they cite most.
When was Good Health, Inc. DBA Premier Pharmacy Services inspected by FDA?
The inspection ran Nov 8 – Nov 16, 2018, and the Form 483 is dated November 29, 2018.
How do I get the full Form 483 for Good Health, Inc. DBA Premier Pharmacy Services?
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.