Nature's Pharmacy & Compounding Center
Form 483 issued November 22, 2013 · Asheville, North Carolina
- Inspection
- Nov 12 – Nov 22, 2013
- Investigator
- Bonita S. Chester
- Observations
- 9
- Pages
- 5
- FEI number
- 3004490277
In short: On November 22, 2013, FDA issued a Form 483 with 9 observations to Nature's Pharmacy & Compounding Center in Asheville, North Carolina (FEI 3004490277) after an inspection that ran Nov 12 – Nov 22, 2013. The investigator was Bonita S. Chester. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and laboratory controls account for 6 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…
- 02
Procedures designed to prevent microbiological contamination of drug ·products purporting to be sterile do not include…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
This inspection in context
Bonita S. Chester
17 documents · 2013–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in North Carolina.
The firmNature's Pharmacy & Compounding Center history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nature's Pharmacy & Compounding Center?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. 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 Nature's Pharmacy & Compounding Center?
Bonita S. Chester is named on this Form 483, for the inspection of Nov 12 – Nov 22, 2013. Each investigator has a profile showing what they cite most.
When was Nature's Pharmacy & Compounding Center inspected by FDA?
The inspection ran Nov 12 – Nov 22, 2013, and the Form 483 is dated November 22, 2013.
How do I get the full Form 483 for Nature's Pharmacy & Compounding Center?
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.