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FDA Inspection
•Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy•April 5, 2019

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy – FDA Inspection, Apr 5, 2019

Record Details

This FDA Inspection record concerns Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy, with an inspection on April 5, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
Inspection Date
April 5, 2019
Product Type
Drugs
Office
Center for Drug Evaluation and Research
People
  • June P. Page (FDA Associated Person)
  • Xiaohui Shen (FDA Associated Person)
View Company Profile

ID · 75f49936-c24b-4474-ba32-16d5855e1045

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
1085801
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued
Enforcement
Warning Letter

FDA Citations

4
  1. FDCA 501(a)(2)(A)Non-microbial contamination, production area
  2. FDCA 501(a)(2)(A)Cleanliness, ISO-classified areas
  3. FDCA 501(a)(2)(A)Ceiling tiles, cleanroom
  4. FDCA 501(a)(2)(A)Hazardous drugs, prevention of cross-contamination

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

1
DateClassificationOfficeProject area
September 9, 2021NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
  • FDA Inspection 1153267 - 2021-09-09

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