Absolutely Natural
Form 483 issued June 14, 2019 · Melbourne, Florida
- Inspection
- Jun 11 – Jun 14, 2019
- Investigator
- Libia M. Lugo
- Observations
- 6
- Pages
- 6
- FEI number
- 3004606446
In short: On June 14, 2019, FDA issued a Form 483 with 6 observations to Absolutely Natural in Melbourne, Florida (FEI 3004606446) after an inspection that ran Jun 11 – Jun 14, 2019. The investigator was Libia M. Lugo. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
- 02
The accuracy, sensitivity and specificity of test methods…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
Each component is not tested for conformity with all appropriate written specifications for…
This inspection in context
Libia M. Lugo
24 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmAbsolutely Natural history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Absolutely Natural?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, production and materials. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Absolutely Natural?
Libia M. Lugo is named on this Form 483, for the inspection of Jun 11 – Jun 14, 2019. Each investigator has a profile showing what they cite most.
When was Absolutely Natural inspected by FDA?
The inspection ran Jun 11 – Jun 14, 2019, and the Form 483 is dated June 14, 2019.
How do I get the full Form 483 for Absolutely Natural?
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.