Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site)
Form 483 issued January 14, 2025 · Jinan, China
- Inspection
- Jan 6 – Jan 14, 2025
- Investigators
- Jeffrey P. Raimondi· Justin A. Boyd
- Observations
- 10
- Pages
- 11
- FEI number
- 3003802432
In short: On January 14, 2025, FDA issued a Form 483 with 10 observations to Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site) in Jinan, Shandong (FEI 3003802432) after an inspection that ran Jan 6 – Jan 14, 2025. The investigators were Jeffrey P. Raimondi and Justin A. Boyd. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 7 of 10 observations.
Most cited: 21 CFR 211.113 (2×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. 1. For Workshop @used…
- 04
There is a failure to thoroughly review any unexplained discrepancy whether or not the…
This inspection in context
Jeffrey P. Raimondi
40 documents · 2017–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmQilu Pharmaceutical Co., Ltd.(High Tech Zone Site) history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site)?
FDA listed 10 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site)?
Jeffrey P. Raimondi and Justin A. Boyd are named on this Form 483, for the inspection of Jan 6 – Jan 14, 2025. Each investigator has a profile showing what they cite most.
When was Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site) inspected by FDA?
The inspection ran Jan 6 – Jan 14, 2025, and the Form 483 is dated January 14, 2025.
How do I get the full Form 483 for Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site)?
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.