Alps Pharmaceutical Ind. Co., Ltd.
Form 483 issued October 13, 2010 · Hida City, Japan
- Inspection
- Oct 13 – Oct 17, 2025
- Investigator
- Kham Phommachanh
- Observations
- 2
- Pages
- 2
- FEI number
- 3002806352
In short: On October 13, 2010, FDA issued a Form 483 with 2 observations to Alps Pharmaceutical Ind. Co., Ltd. in Hida City, Gifu Prefecture (FEI 3002806352) after an inspection that ran Oct 13 – Oct 17, 2025. The investigator was Kham Phommachanh. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.160 (2×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
QC laboratory established written procedure for synchronization of laboratory instruments time with the actual…
- 02
Microbiological laboratory lacked established written procedure for cleaning of incubators and labeling of prepared media…
This inspection in context
Kham Phommachanh
12 documents · 2009–2024
Cites 211.194 (laboratory records) more than any other section. Most of their documents are for sites in Canada.
The firmAlps Pharmaceutical Ind. Co., Ltd. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alps Pharmaceutical Ind. Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Alps Pharmaceutical Ind. Co., Ltd.?
Kham Phommachanh is named on this Form 483, for the inspection of Oct 13 – Oct 17, 2025. Each investigator has a profile showing what they cite most.
When was Alps Pharmaceutical Ind. Co., Ltd. inspected by FDA?
The inspection ran Oct 13 – Oct 17, 2025, and the Form 483 is dated October 13, 2010.
How do I get the full Form 483 for Alps Pharmaceutical Ind. 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.