Teh Seng Pharmaceutical Mfg. Co., Ltd.
Form 483 issued August 4, 2023 · Tainan City, Taiwan
- Inspection
- Jul 31 – Aug 4, 2023
- Investigator
- Bryan A. Galvez
- Observations
- 2
- Pages
- 2
- FEI number
- 3003834002
In short: On August 4, 2023, FDA issued a Form 483 with 2 observations to Teh Seng Pharmaceutical Mfg. Co., Ltd. in Tainan City, Taiwan (FEI 3003834002) after an inspection that ran Jul 31 – Aug 4, 2023. The investigator was Bryan A. Galvez. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.160 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure…
- 02
Investigations of an unexplained discrepancy…
This inspection in context
Bryan A. Galvez
15 documents · 2018–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmTeh Seng Pharmaceutical Mfg. Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Teh Seng Pharmaceutical Mfg. Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and 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 Teh Seng Pharmaceutical Mfg. Co., Ltd.?
Bryan A. Galvez is named on this Form 483, for the inspection of Jul 31 – Aug 4, 2023. Each investigator has a profile showing what they cite most.
When was Teh Seng Pharmaceutical Mfg. Co., Ltd. inspected by FDA?
The inspection ran Jul 31 – Aug 4, 2023, and the Form 483 is dated August 4, 2023.
How do I get the full Form 483 for Teh Seng Pharmaceutical Mfg. Co., Ltd.?
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.