Home / Inspections / 1157834

1157834

Zhang Medical P.C. d/b/a New Hope Fertility Center — FEI 3008769612

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
November 30, 2021
Fiscal Year
2022
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
New York, NY (United States)

Facility

Other inspections at this facility

  • 1230684 (NAI Thu Feb 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1199081 (NAI Fri Mar 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1065547 (VAI Thu Sep 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 972646 (VAI Tue May 31 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 895283 (OAI Mon Sep 15 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1223021 CFR 1271.50(a)Responsible person to determine, document
1224121 CFR 1271.55(b)(4)Reasons for ineligibility on summary
1224721 CFR 1271.55(d)(2)Accurate, indelible, legible
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1228621 CFR 1271.80(b)Specimen collections not timely
1249321 CFR 1271.90(c)Eligibility not required--warning labels
145221 CFR 211.113(b)Validation lacking for sterile drug products
188521 CFR 211.165(b)Microbiological testing
357021 CFR 211.100(a)Approval and review of procedures
360321 CFR 211.160(b)Scientifically sound laboratory controls
436421 CFR 211.176Failing to test for penicillin cross-contamination