Winco Mfg., LLC
FDA inspection history in Ocala, Florida, 2018
- 1
- Form 483
Every document, by year
- Form 483
2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Ocala, Florida.
Cited most
Across all Winco Mfg. observations on file
- 21 CFR 803.17(a)(3)What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 803.50(a)(1)If I am a manufacturer, what reporting requirements apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.198(a)Complaint files1
- 21 CFR 820.50Purchasing controls1
The complete Winco Mfg. file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Ocala, Florida
One Form 483 · 2018 · 6 observations
Latest: Form 483, Jul 12, 2018 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-07-12 | 483 Form 483 | Ocala, Florida | 6 | $99 |
Investigators on these documents
FEI number 1027229 · most recent document Jul 12, 2018
About Winco Mfg., LLC
How many FDA Form 483s has Winco Mfg., LLC received?
FDA Intel has 1 Form 483 on file for Winco Mfg., LLC; the most recent is dated Jul 12, 2018.
When was Winco Mfg., LLC last inspected by FDA?
The most recent FDA inspection document on file for Winco Mfg., LLC is a Form 483 dated Jul 12, 2018, for the site in Ocala, Florida.
What did FDA cite at Winco Mfg., LLC?
The regulations cited most in the observations on file for Winco Mfg., LLC are 21 CFR 803.17(a)(3) (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 803.50(a)(1) (If I am a manufacturer, what reporting requirements apply to me?), 1 time; 21 CFR 820.100(a) (Corrective and preventive action), 1 time.