Siddha Flower Essences LLC
Form 483 issued December 12, 2018 · Oxnard, California
- Inspection
- Dec 10 – Dec 12, 2018
- Investigator
- Christopher M. Jenner
- Observations
- 6
- Pages
- 3
- FEI number
- 3014145088
In short: On December 12, 2018, FDA issued a Form 483 with 6 observations to Siddha Flower Essences LLC in Oxnard, California (FEI 3014145088) after an inspection that ran Dec 10 – Dec 12, 2018. The investigator was Christopher M. Jenner. Most observations concern quality system 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
Quality system and materials account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Drug product component testing is deficient in that at least one specific test to verify the…
- 02
Component testing is deficient in that each component is not tested for conformity with all appropriate…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Written procedures are not established for evaluations done at least annually and including provisions for a…
This inspection in context
Christopher M. Jenner
11 documents · 2017–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Arizona.
The firmSiddha Flower Essences 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 211.84(d)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Siddha Flower Essences LLC?
FDA listed 6 observations on this Form 483, mostly about quality system, materials and production. 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 Siddha Flower Essences LLC?
Christopher M. Jenner is named on this Form 483, for the inspection of Dec 10 – Dec 12, 2018. Each investigator has a profile showing what they cite most.
When was Siddha Flower Essences LLC inspected by FDA?
The inspection ran Dec 10 – Dec 12, 2018, and the Form 483 is dated December 12, 2018.
How do I get the full Form 483 for Siddha Flower Essences 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.