Alps Pharmaceutical Ind. Co., Ltd.
Form 483 issued April 5, 2019 · Hida, Japan
- Inspection
- Apr 1 – Apr 5, 2019
- Investigators
- Linda F. Murphy· Zhongren Tu
- Observations
- 2
- Pages
- 3
- FEI number
- 3002806352
In short: On April 5, 2019, FDA issued a Form 483 with 2 observations to Alps Pharmaceutical Ind. Co., Ltd. in Hida, Japan (FEI 3002806352) after an inspection that ran Apr 1 – Apr 5, 2019. The investigators were Linda F. Murphy and Zhongren Tu. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to clean equipment and utensils to prevent contamination or carry-over of a material that would…
- 02
Written procedures for cleaning and maintenance fail to include description in sufficient detail of the methods…
This inspection in context
Linda F. Murphy
23 documents · 2015–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in India.
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 211.67
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 facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Alps Pharmaceutical Ind. Co., Ltd.?
Linda F. Murphy and Zhongren Tu are named on this Form 483, for the inspection of Apr 1 – Apr 5, 2019. Each investigator has a profile showing what they cite most.
When was Alps Pharmaceutical Ind. Co., Ltd. inspected by FDA?
The inspection ran Apr 1 – Apr 5, 2019, and the Form 483 is dated April 5, 2019.
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.