In Your Atmosphere Holdings LLC
Form 483 issued January 12, 2017 · Santa Fe, New Mexico
- Inspection
- Jan 9 – Jan 12, 2017
- Investigators
- Nayan J. Patel· Zachary A. Bogorad
- Observations
- 8
- Pages
- 4
- FEI number
- 3013159937
In short: On January 12, 2017, FDA issued a Form 483 with 8 observations to In Your Atmosphere Holdings LLC in Santa Fe, New Mexico (FEI 3013159937) after an inspection that ran Jan 9 – Jan 12, 2017. The investigators were Nayan J. Patel and Zachary A. Bogorad. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and quality system account for 5 of 8 observations.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 02
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Laboratory controls do not include the establishment ofscientifically sound and appropriate specifications, standards, sampling plans, and…
This inspection in context
Nayan J. Patel
11 documents · 2017–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Utah.
The firmIn Your Atmosphere Holdings LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at In Your Atmosphere Holdings LLC?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected In Your Atmosphere Holdings LLC?
Nayan J. Patel and Zachary A. Bogorad are named on this Form 483, for the inspection of Jan 9 – Jan 12, 2017. Each investigator has a profile showing what they cite most.
When was In Your Atmosphere Holdings LLC inspected by FDA?
The inspection ran Jan 9 – Jan 12, 2017, and the Form 483 is dated January 12, 2017.
How do I get the full Form 483 for In Your Atmosphere Holdings 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.