Shouguang Fukang Pharmaceutical Co., Ltd.
Form 483 issued May 25, 2018 · Shouguang, China
- Inspection
- May 21 – May 25, 2018
- Observations
- 5
- Pages
- 6
- FEI number
- 3003941038
In short: On May 25, 2018, FDA issued a Form 483 with 5 observations to Shouguang Fukang Pharmaceutical Co., Ltd. in Shouguang, Shandong (FEI 3003941038) after an inspection that ran May 21 – May 25, 2018. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
3 of 5 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
Data generated in the QC…
- 02
Drug substances failing specifications are commercially…
- 03
Equipment used to manufacture drug substances…
- 04
Drug substances or the components are not…
This inspection in context
Questions about this 483
What did FDA find at Shouguang Fukang Pharmaceutical Co., Ltd.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
When was Shouguang Fukang Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran May 21 – May 25, 2018, and the Form 483 is dated May 25, 2018.
How do I get the full Form 483 for Shouguang Fukang 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.