Jiangsu Alpha Pharmaceutical Co., Ltd.
Form 483 issued January 25, 2019 · Suqian, China
- Inspection
- Jan 22 – Jan 25, 2019
- Investigator
- Joel D. Hustedt
- Observations
- 6
- Pages
- 2
- FEI number
- 3011765771
In short: On January 25, 2019, FDA issued a Form 483 with 6 observations to Jiangsu Alpha Pharmaceutical Co., Ltd. in Suqian, Jiangsu (FEI 3011765771) after an inspection that ran Jan 22 – Jan 25, 2019. The investigator was Joel D. Hustedt. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Laboratory controls and facilities & equipment account for 5 of 6 observations.
Most cited: 21 CFR 211.67 (2×) · 211.166 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Master production records do not contain all instructions related to the…
- 02
On 01/22/2019, visible residue, possible corrosion on a pipe, and a deteriorating gasket were observed upon…
- 03
(>) (4) transfer drums used to transfer the a intermediate solution for subsequent manufacturing steps lwere…
- 04
On 01/23/2019, firm personnel could not demonstrate that their re-testing activities for two OOS investigations lwere…
This inspection in context
Joel D. Hustedt
25 documents · 2009–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in China.
The firmJiangsu Alpha Pharmaceutical Co., Ltd. history
The site's inspection history, in date order.
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 Jiangsu Alpha Pharmaceutical Co., Ltd.?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Jiangsu Alpha Pharmaceutical Co., Ltd.?
Joel D. Hustedt is named on this Form 483, for the inspection of Jan 22 – Jan 25, 2019. Each investigator has a profile showing what they cite most.
When was Jiangsu Alpha Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Jan 22 – Jan 25, 2019, and the Form 483 is dated January 25, 2019.
How do I get the full Form 483 for Jiangsu Alpha Pharmaceutical 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.