Avista Pharma Solutions, Inc. dba Cambrex
Form 483 issued May 3, 2024 · Longmont, Colorado
- Inspection
- Apr 30 – May 3, 2024
- Investigators
- Michael S. Budziak· Miguel A. Martinez
- Observations
- 4
- Pages
- 6
- FEI number
- 3012316957
In short: On May 3, 2024, FDA issued a Form 483 with 4 observations to Avista Pharma Solutions, Inc. dba Cambrex in Longmont, Colorado (FEI 3012316957) after an inspection that ran Apr 30 – May 3, 2024. The investigators were Michael S. Budziak and Miguel A. Martinez. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Quality system and laboratory controls account for 4 of 4 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Employees are not given training in the particular operations they perform as…
- 03
Laboratory records do not include complete records of the periodic…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Michael S. Budziak
1 document · 2024
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Colorado.
The firmAvista Pharma Solutions, Inc. dba Cambrex history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Avista Pharma Solutions, Inc. dba Cambrex?
FDA listed 4 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Avista Pharma Solutions, Inc. dba Cambrex?
Michael S. Budziak and Miguel A. Martinez are named on this Form 483, for the inspection of Apr 30 – May 3, 2024. Each investigator has a profile showing what they cite most.
When was Avista Pharma Solutions, Inc. dba Cambrex inspected by FDA?
The inspection ran Apr 30 – May 3, 2024, and the Form 483 is dated May 3, 2024.
How do I get the full Form 483 for Avista Pharma Solutions, Inc. dba Cambrex?
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.