Rapid Equine Solutions, LLC
Amended 483 issued August 9, 2020 · Aston, Pennsylvania
- Inspection
- Jul 22, 2019 – Aug 9, 2020
- Investigator
- Christina K. Theodorou
- Observations
- 8
- Pages
- 5
- FEI number
- 3006708880
In short: On August 9, 2020, FDA issued a Amended 483 with 8 observations to Rapid Equine Solutions, LLC in Aston, Pennsylvania (FEI 3006708880) after an inspection that ran Jul 22, 2019 – Aug 9, 2020. The investigator was Christina K. Theodorou. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Buildings used in the manufacture, processing, packing or holding of drug products are not free of…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
4 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Christina K. Theodorou
19 documents · 2016–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmRapid Equine Solutions, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar documentsOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Rapid Equine Solutions, LLC?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Rapid Equine Solutions, LLC?
Christina K. Theodorou is named on this Amended 483, for the inspection of Jul 22, 2019 – Aug 9, 2020. Each investigator has a profile showing what they cite most.
When was Rapid Equine Solutions, LLC inspected by FDA?
The inspection ran Jul 22, 2019 – Aug 9, 2020, and the Amended 483 is dated August 9, 2020.
How do I get the full Amended 483 for Rapid Equine Solutions, LLC?
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.