Precision Equine, LLC
483 response sent October 16, 2023 · California
- Observations
- 8
- Pages
- 16
- FEI number
- 3005698544
In short: This is Precision Equine, LLC's written response to FDA, dated October 16, 2023, for its site in California (FEI 3005698544). It sets out the corrective actions the firm committed to.
What the firm responded to
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…
- 04
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and…
4 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full responseThis inspection in context
Questions about this response
When was Precision Equine, LLC inspected by FDA?
This 483 response is dated October 16, 2023.
How do I get the full 483 response for Precision Equine, LLC?
Download the original PDF from FDA Intel for $199, with no subscription. You also get an invoice PDF with the order.