Hartley Medical Center Pharmacy, Incorporated
Form 483 issued July 8, 2015 · Long Beach, California
- Inspection
- Jun 29 – Jul 8, 2015
- Investigators
- Caryn M. McNab· Drew M. Love· Jennifer M. Gogley
- Observations
- 6
- Pages
- 3
- FEI number
- 3011630209
In short: On July 8, 2015, FDA issued a Form 483 with 6 observations to Hartley Medical Center Pharmacy, Incorporated in Long Beach, California (FEI 3011630209) after an inspection that ran Jun 29 – Jul 8, 2015. The investigators were Caryn M. McNab, Drew M. Love and Jennifer M. Gogley. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
This inspection in context
Caryn M. McNab
7 documents · 2013–2023
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 211.28(a)
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 6 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. 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 Hartley Medical Center Pharmacy, Incorporated?
Caryn M. McNab, Drew M. Love and Jennifer M. Gogley are named on this Form 483, for the inspection of Jun 29 – Jul 8, 2015. Each investigator has a profile showing what they cite most.
When was Hartley Medical Center Pharmacy, Incorporated inspected by FDA?
The inspection ran Jun 29 – Jul 8, 2015, and the Form 483 is dated July 8, 2015.
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.