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FDA Inspection
•Stillmeadow Incorporated•August 23, 2018

Stillmeadow Incorporated – FDA Inspection, Aug 23, 2018

Record Details

This FDA Inspection record concerns Stillmeadow Incorporated, with an inspection on August 23, 2018, issued by the Dallas District Office, covering animal drugs & feeds.

Company
Stillmeadow Incorporated
Inspection Date
August 23, 2018
Product Type
Animal Drugs & Feeds
Office
Dallas District Office
Person
  • Leighton K. Ngai (Company Rep)
View Company Profile

ID · 9ec58cfc-c6fc-4f64-989f-15c5ee54ccd6

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
1063319
FDA center
Animal Drugs & Feeds
Project area
Pre-Approval Eval. of Animal Drugs and Food Additives
Outcome
Form 483 issued

FDA Citations

16
  1. 21 CFR 58.130(e)Conduct: changes not obscuring original entries
  2. 21 CFR 58.185(a)(11)Final report: operations on data, analysis of data
  3. 21 CFR 58.185(a)(12)Final report: reports of individual scientists
  4. 21 CFR 58.185(a)(14)Final report: statement by QAU
  5. 21 CFR 58.185(a)(2)Final report: objectives, procedures, changes
  6. 21 CFR 58.185(a)(4)Final report: data on test and control articles
  7. 21 CFR 58.185(a)(6)Final report: description of methods
  8. 21 CFR 58.185(a)(8)Final report: dosage, regimen, route of admin., duration
  9. 21 CFR 58.185(a)(9)Final report: circumstances affecting data qual., integrity
  10. 21 CFR 58.29(b)Personnel: summary of training, job description

Showing 10 of 16 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Stillmeadow Incorporated

2
DateClassificationOfficeProject area
August 23, 2023VAIDallas District Office
December 9, 2016Not classifiedDallas District Office
Other documents for Stillmeadow Incorporated
  • FDA Inspection 1217190 - 2023-08-23
  • FDA Inspection 995047 - 2016-12-09

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