Calvin Scott & Company, Inc.
Form 483 issued June 19, 2023 · Albuquerque, New Mexico
- Inspection
- Jun 14 – Jun 19, 2023
- Investigator
- Cecilia H. Kieu
- Observations
- 1
- Pages
- 5
- FEI number
- 1619076
In short: On June 19, 2023, FDA issued a Form 483 with 1 observation to Calvin Scott & Company, Inc. in Albuquerque, New Mexico (FEI 1619076) after an inspection that ran Jun 14 – Jun 19, 2023. The investigator was Cecilia H. Kieu. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Cecilia H. Kieu
13 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmCalvin Scott & Company, Inc. 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 Calvin Scott & Company, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Calvin Scott & Company, Inc.?
Cecilia H. Kieu is named on this Form 483, for the inspection of Jun 14 – Jun 19, 2023. Each investigator has a profile showing what they cite most.
When was Calvin Scott & Company, Inc. inspected by FDA?
The inspection ran Jun 14 – Jun 19, 2023, and the Form 483 is dated June 19, 2023.
How do I get the full Form 483 for Calvin Scott & Company, Inc.?
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.