Precision Equine, LLC
Form 483 issued September 22, 2023 · Bakersfield, California
- Inspection
- Aug 23 – Sep 22, 2023
- Investigators
- Julia N. Alvarez· Sara H. Gabel· Taichun Qin
- Observations
- 8
- Pages
- 8
- FEI number
- 3005698544
In short: On September 22, 2023, FDA issued a Form 483 with 8 observations to Precision Equine, LLC in Bakersfield, California (FEI 3005698544) after an inspection that ran Aug 23 – Sep 22, 2023. The investigators were Julia N. Alvarez, Sara H. Gabel and Taichun Qin. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and quality system account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
There is no written testing program designed to assess the stability…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and…
This inspection in context
Julia N. Alvarez
2 documents · 2023–2024
Cites 211.165(a) (testing and release for distribution) more than any other section. Most of their documents are for sites in California.
The firmPrecision Equine, LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Precision Equine, LLC?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Precision Equine, LLC?
Julia N. Alvarez, Sara H. Gabel and Taichun Qin are named on this Form 483, for the inspection of Aug 23 – Sep 22, 2023. Each investigator has a profile showing what they cite most.
When was Precision Equine, LLC inspected by FDA?
The inspection ran Aug 23 – Sep 22, 2023, and the Form 483 is dated September 22, 2023.
How do I get the full Form 483 for Precision Equine, LLC?
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