Hartley Medical Center Pharmacy, Incorporated
Form 483 issued March 24, 2017 · Long Beach, California
- Inspection
- Mar 20 – Mar 24, 2017
- Investigator
- Roger F. Zabinski
- Observations
- 2
- Pages
- 1
- FEI number
- 3011630209
In short: On March 24, 2017, FDA issued a Form 483 with 2 observations to Hartley Medical Center Pharmacy, Incorporated in Long Beach, California (FEI 3011630209) after an inspection that ran Mar 20 – Mar 24, 2017. The investigator was Roger F. Zabinski. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.113 (1×) · 211.42 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment, materials, and/or supplies are not disinfected prior to entering…
- 02
The ISO-classified areas have difficult to clean, particle-generating, or visibly…
This inspection in context
Roger F. Zabinski
36 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmHartley Medical Center Pharmacy, Incorporated history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hartley Medical Center Pharmacy, Incorporated?
FDA listed 2 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Hartley Medical Center Pharmacy, Incorporated?
Roger F. Zabinski is named on this Form 483, for the inspection of Mar 20 – Mar 24, 2017. Each investigator has a profile showing what they cite most.
When was Hartley Medical Center Pharmacy, Incorporated inspected by FDA?
The inspection ran Mar 20 – Mar 24, 2017, and the Form 483 is dated March 24, 2017.
How do I get the full Form 483 for Hartley Medical Center Pharmacy, Incorporated?
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.