Alps Pharmaceutical Ind. Co., Ltd.
Form 483 issued May 26, 2023 · Hida-shi, Japan
- Inspection
- May 22 – May 26, 2023
- Observations
- 3
- Pages
- 2
In short: On May 26, 2023, FDA issued a Form 483 with 3 observations to Alps Pharmaceutical Ind. Co., Ltd. in Hida-shi, Gifu after an inspection that ran May 22 – May 26, 2023. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and laboratory controls account for 2 of 3 observations.
Most cited: 21 CFR 211.68 (1×) · 211.194 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to validate your software system used…
- 02
cGMP records lack controls to…
- 03
Your firm failed to verify analytical methods used…
This inspection in context
Questions about this 483
What did FDA find at Alps Pharmaceutical Ind. Co., Ltd.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
When was Alps Pharmaceutical Ind. Co., Ltd. inspected by FDA?
The inspection ran May 22 – May 26, 2023, and the Form 483 is dated May 26, 2023.
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.