Reliable Rexall-A Compounding Pharmacy
Form 483 issued March 29, 2016 · San Francisco, California
- Inspection
- Mar 18 – Mar 29, 2016
- Investigators
- Kristin M. Abaonza· Lucila B. Nwatu
- Observations
- 8
- Pages
- 10
- FEI number
- 3006164918
In short: On March 29, 2016, FDA issued a Form 483 with 8 observations to Reliable Rexall-A Compounding Pharmacy in San Francisco, California (FEI 3006164918) after an inspection that ran Mar 18 – Mar 29, 2016. The investigators were Kristin M. Abaonza and Lucila B. Nwatu. Most observations concern laboratory controls and materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
No appropriate investigation was conducted when a retumed dmg product appeared to implicate associated…
- 02
Results of stability testing are not used…
- 03
Failure to reject any lot of components that did not meet the appropriate written specifications for…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Kristin M. Abaonza
12 documents · 2015–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmReliable Rexall-A Compounding Pharmacy history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.204
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Reliable Rexall-A Compounding Pharmacy?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, materials and quality system. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Reliable Rexall-A Compounding Pharmacy?
Kristin M. Abaonza and Lucila B. Nwatu are named on this Form 483, for the inspection of Mar 18 – Mar 29, 2016. Each investigator has a profile showing what they cite most.
When was Reliable Rexall-A Compounding Pharmacy inspected by FDA?
The inspection ran Mar 18 – Mar 29, 2016, and the Form 483 is dated March 29, 2016.
How do I get the full Form 483 for Reliable Rexall-A Compounding Pharmacy?
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