Melaleuca
Form 483 issued August 9, 2019 · Idaho Falls, Idaho
- Investigator
- Alan P. Kurtzberg
- Observations
- 2
- Pages
- 1
- FEI number
- 3021937
In short: On August 9, 2019, FDA issued a Form 483 with 2 observations to Melaleuca in Idaho Falls, Idaho (FEI 3021937). The investigator was Alan P. Kurtzberg. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.100(a) (1×) · 211.160(b)(4) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are…
This inspection in context
Alan P. Kurtzberg
24 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmMelaleuca history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Melaleuca?
FDA listed 2 observations on this Form 483, mostly about production and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Melaleuca?
Alan P. Kurtzberg is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Melaleuca inspected by FDA?
This Form 483 is dated August 9, 2019.
How do I get the full Form 483 for Melaleuca?
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.