S & J International Enterprises Public Company Limited Branch
Form 483 issued July 21, 2023 · SI RACHA, Thailand
- Inspection
- Jul 17 – Jul 21, 2023
- Investigator
- James R. Birkenstamm
- Observations
- 3
- Pages
- 3
- FEI number
- 3005979923
In short: On July 21, 2023, FDA issued a Form 483 with 3 observations to S & J International Enterprises Public Company Limited Branch in SI RACHA, Thailand (FEI 3005979923) after an inspection that ran Jul 17 – Jul 21, 2023. The investigator was James R. Birkenstamm. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
2 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory records do not include complete records of any testing and standardization…
- 02
Laboratory records do not include a record of all calculations performed in…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
James R. Birkenstamm
12 documents · 2018–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmS & J International Enterprises Public Company Limited Branch history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at S & J International Enterprises Public Company Limited Branch?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected S & J International Enterprises Public Company Limited Branch?
James R. Birkenstamm is named on this Form 483, for the inspection of Jul 17 – Jul 21, 2023. Each investigator has a profile showing what they cite most.
When was S & J International Enterprises Public Company Limited Branch inspected by FDA?
The inspection ran Jul 17 – Jul 21, 2023, and the Form 483 is dated July 21, 2023.
How do I get the full Form 483 for S & J International Enterprises Public Company Limited Branch?
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.