NOVACYL (THAILAND) LIMITED
FDA inspection history in MUEANG SAMUT PRAKAN, Thailand, 2015 to 2018
- 1
- Close-out
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Close-out
- Form 483
- Warning letter
2015: one warning letter; 2018: one close-out letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One warning letter, at MUEANG SAMUT PRAKAN, Thailand.
- 2018One close-out letter and one Form 483, at MUEANG SAMUT PRAKAN, Thailand.
Cited most
Across all NOVACYL (THAILAND) LIMITED observations on file
- 21 CFR 211.192Production record review1
- 21 CFR 211.198Complaint files1
The complete NOVACYL (THAILAND) LIMITED file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
MUEANG SAMUT PRAKAN, Thailand
One close-out letter, one Form 483 and one warning letter · 2015 to 2018
Latest: Close-out, May 17, 2018 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-05-17 | Close-out Close-out letter | MUEANG SAMUT PRAKAN, Thailand | — | $99 |
| 2018-03-23 | 483 Form 483 | MUEANG SAMUT PRAKAN, Thailand | — | $99 |
| 2015-02-27 | Warning letter Warning letter | MUEANG SAMUT PRAKAN, Thailand | — | $99 |
Investigators on these documents
FEI number 3000287096 · most recent document May 17, 2018
About NOVACYL (THAILAND) LIMITED
How many FDA Form 483s has NOVACYL (THAILAND) LIMITED received?
FDA Intel has 1 Form 483 on file for NOVACYL (THAILAND) LIMITED; the most recent is dated Mar 23, 2018.
When was NOVACYL (THAILAND) LIMITED last inspected by FDA?
The most recent FDA inspection document on file for NOVACYL (THAILAND) LIMITED is a Form 483 dated Mar 23, 2018, for the site in MUEANG SAMUT PRAKAN, Thailand.
What did FDA cite at NOVACYL (THAILAND) LIMITED?
The regulations cited most in the observations on file for NOVACYL (THAILAND) LIMITED are 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.198 (Complaint files), 1 time.
Has NOVACYL (THAILAND) LIMITED received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for NOVACYL (THAILAND) LIMITED; the most recent is dated Feb 27, 2015.