General Air Service & Supply Co.
Form 483 issued March 25, 2022 · Commerce City, Colorado
- Inspection
- Mar 22 – Mar 25, 2022
- Investigators
- Gunneet Kaur· Tiara M. Brown
- Observations
- 6
- Pages
- 6
- FEI number
- 1717152
In short: On March 25, 2022, FDA issued a Form 483 with 6 observations to General Air Service & Supply Co. in Commerce City, Colorado (FEI 1717152) after an inspection that ran Mar 22 – Mar 25, 2022. The investigators were Gunneet Kaur and Tiara M. Brown. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 4 of 6 observations.
Most cited: 21 CFR 211.100(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Written production and process control procedures are not followed in the execution of production…
- 02
Deviations from written production and process control procedures are…
- 03
The calibration of instruments is not…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Gunneet Kaur
9 documents · 2021–2024
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmGeneral Air Service & Supply Co. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at General Air Service & Supply Co.?
FDA listed 6 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected General Air Service & Supply Co.?
Gunneet Kaur and Tiara M. Brown are named on this Form 483, for the inspection of Mar 22 – Mar 25, 2022. Each investigator has a profile showing what they cite most.
When was General Air Service & Supply Co. inspected by FDA?
The inspection ran Mar 22 – Mar 25, 2022, and the Form 483 is dated March 25, 2022.
How do I get the full Form 483 for General Air Service & Supply Co.?
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