NOVACYL (THAILAND) LIMITED
Form 483 issued March 23, 2018 · MUEANG SAMUT PRAKAN, Thailand
- Investigator
- Zhongren Wu
- Observations
- 1
- Pages
- 2
- FEI number
- 3000287096
In short: On March 23, 2018, FDA issued a Form 483 with 1 observation to NOVACYL (THAILAND) LIMITED in MUEANG SAMUT PRAKAN, Thailand (FEI 3000287096). The investigator was Zhongren Wu. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.198 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
This inspection in context
Zhongren Wu
8 documents · 2015–2021
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Maryland.
The firmNOVACYL (THAILAND) LIMITED history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
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 NOVACYL (THAILAND) LIMITED?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected NOVACYL (THAILAND) LIMITED?
Zhongren Wu is named on this Form 483. Each investigator has a profile showing what they cite most.
When was NOVACYL (THAILAND) LIMITED inspected by FDA?
This Form 483 is dated March 23, 2018.
How do I get the full Form 483 for NOVACYL (THAILAND) LIMITED?
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.