Organicare Nature's Science, LLC
Form 483 issued December 1, 2023 · Austin, Texas
- Inspection
- Nov 27 – Dec 1, 2023
- Investigator
- Shanna N. Purdy
- Observations
- 3
- Pages
- 4
- FEI number
- 3013202192
In short: On December 1, 2023, FDA issued a Form 483 with 3 observations to Organicare Nature's Science, LLC in Austin, Texas (FEI 3013202192) after an inspection that ran Nov 27 – Dec 1, 2023. The investigator was Shanna N. Purdy. Most observations concern quality system and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 03
Written records of major equipment cleaning, maintenance and use are not included…
This inspection in context
Shanna N. Purdy
7 documents · 2019–2023
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in Texas.
The firmOrganicare Nature's Science, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Organicare Nature's Science, LLC?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Organicare Nature's Science, LLC?
Shanna N. Purdy is named on this Form 483, for the inspection of Nov 27 – Dec 1, 2023. Each investigator has a profile showing what they cite most.
When was Organicare Nature's Science, LLC inspected by FDA?
The inspection ran Nov 27 – Dec 1, 2023, and the Form 483 is dated December 1, 2023.
How do I get the full Form 483 for Organicare Nature's Science, LLC?
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.