Tenda Horse Products LLC
Form 483 issued May 17, 2024 · Sandusky, Ohio
- Inspection
- May 14 – May 17, 2024
- Investigator
- Paranthaman Senthamaraikannan
- Observations
- 6
- Pages
- 5
- FEI number
- 3005916117
In short: On May 17, 2024, FDA issued a Form 483 with 6 observations to Tenda Horse Products LLC in Sandusky, Ohio (FEI 3005916117) after an inspection that ran May 14 – May 17, 2024. The investigator was Paranthaman Senthamaraikannan. Most observations concern quality system and production.
At a glance
Quality system and production account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 02
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 03
Employees are not given training in…
- 04
Written records of major equipment cleaning are not included…
This inspection in context
Paranthaman Senthamaraikannan
6 documents · 2022–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Ohio.
The firmTenda Horse Products LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tenda Horse Products LLC?
FDA listed 6 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Tenda Horse Products LLC?
Paranthaman Senthamaraikannan is named on this Form 483, for the inspection of May 14 – May 17, 2024. Each investigator has a profile showing what they cite most.
When was Tenda Horse Products LLC inspected by FDA?
The inspection ran May 14 – May 17, 2024, and the Form 483 is dated May 17, 2024.
How do I get the full Form 483 for Tenda Horse Products 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.