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FDA Inspection
•Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park)•June 9, 2023

Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park) – FDA Inspection, Jun 9, 2023

Record Details

This FDA Inspection record concerns Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park), with an inspection on June 9, 2023, issued by the Office of Inspections and Investigations.

Company
Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park)
Inspection Date
June 9, 2023
Office
Office of Inspections and Investigations
Person
  • Matthew B. Casale (FDA Associated Person)
View Company Profile

ID · c12853c6-7a01-461a-82d2-2b8f87d20c75

Inspection Facts

Inspection number
1209772
FDA center
Human Drugs
Outcome
Form 483 issued

FDA Citations

3
  1. 21 CFR 211.113(b)Procedures for sterile drug products
  2. 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
  3. 21 CFR 211.42(c)(10)Aseptic Processing Area

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park)

3
DateClassificationOfficeProject area
May 8, 2026Not classifiedOffice of Inspections and Investigations
June 28, 2019Not classifiedOffice of Inspections and Investigations
March 1, 2019Not classifiedOffice of Inspections and Investigations
Other documents for Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park)
  • FDA Inspection 1322276 - 2026-05-08
  • FDA Inspection 1096968 - 2019-06-28
  • FDA Inspection 1087439 - 2019-03-01

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