Precision Equine, LLC
FDA inspection history across 2 sites, 2023 to 2024
- 2
- Responses
- 1
- Untitled letter
- 1
- Form 483
Every document, by year
- Response
- Untitled letter
- Form 483
2023: one 483 response and one Form 483; 2024: one untitled letter response and one untitled letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2023–24One 483 response, one Form 483, one untitled letter response and one untitled letter, at California and Bakersfield, California.
Cited most
Across all Precision Equine observations on file
- 21 CFR 211.165(a)Testing and release for distribution2
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22(a)Responsibilities of quality control unit1
The complete Precision Equine file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
California
One untitled letter response, one untitled letter and one 483 response · 2023 to 2024
Latest: Response, Sep 10, 2024 →Bakersfield, California
One Form 483 · 2023 · 8 observations
Latest: Form 483, Sep 22, 2023 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-09-10 | Response Untitled letter response | California | — | $199 |
| 2024-07-30 | Untitled letter Untitled letter | California | — | $99 |
| 2023-10-16 | Response 483 response | California | — | $199 |
| 2023-09-22 | 483 Form 483 | Bakersfield, California | 8 | $99 |
Investigators on these documents
FEI number 3005698544 · most recent document Sep 10, 2024
About Precision Equine, LLC
How many FDA Form 483s has Precision Equine, LLC received?
FDA Intel has 1 Form 483 on file for Precision Equine, LLC; the most recent is dated Sep 22, 2023.
When was Precision Equine, LLC last inspected by FDA?
The most recent FDA inspection document on file for Precision Equine, LLC is a Form 483 dated Sep 22, 2023, for the site in Bakersfield, California.
What did FDA cite at Precision Equine, LLC?
The regulations cited most in the observations on file for Precision Equine, LLC are 21 CFR 211.165(a) (Testing and release for distribution), 2 times; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time; 21 CFR 211.166(a) (Stability testing), 1 time.
Has Precision Equine, LLC received an FDA untitled letter?
Yes. FDA Intel has 1 FDA untitled letter on file for Precision Equine, LLC; the most recent is dated Jul 30, 2024. An untitled letter is FDA's enforcement letter for violations that don't rise to warning-letter level.