Shouguang Fukang Pharmaceutical Co., Ltd.
Form 483 issued February 21, 2025 · Shouguang City, China
- Inspection
- Feb 17 – Feb 21, 2025
- Investigators
- Marcus A. Ray· Marvin D. Jones
- Observations
- 9
- Pages
- 7
- FEI number
- 3003941038
In short: On February 21, 2025, FDA issued a Form 483 with 9 observations to Shouguang Fukang Pharmaceutical Co., Ltd. in Shouguang City, Shandong (FEI 3003941038) after an inspection that ran Feb 17 – Feb 21, 2025. The investigators were Marcus A. Ray and Marvin D. Jones. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Facilities & equipment and production account for 6 of 9 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks responsibility to approve final testing…
- 02
Equipment is not cleaned or maintained at appropriate intervals to prevent contamination that would alter the…
- 03
Separate or defined areas to prevent contamination are deficient regarding operations related to the storage of…
- 04
The firm has failed to identify all critical control steps…
This inspection in context
Marcus A. Ray
14 documents · 2017–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in China.
The firmShouguang Fukang Pharmaceutical Co., Ltd. history
All 2 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 Shouguang Fukang Pharmaceutical Co., Ltd.?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Shouguang Fukang Pharmaceutical Co., Ltd.?
Marcus A. Ray and Marvin D. Jones are named on this Form 483, for the inspection of Feb 17 – Feb 21, 2025. Each investigator has a profile showing what they cite most.
When was Shouguang Fukang Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Feb 17 – Feb 21, 2025, and the Form 483 is dated February 21, 2025.
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.