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FDA Inspection
•Medline Industries, LP•July 18, 2025

Medline Industries, LP – FDA Inspection, Jul 18, 2025

Record Details

This FDA Inspection record concerns Medline Industries, LP, with an inspection on July 18, 2025, issued by the Minneapolis District Office, covering human drugs.

Company
Medline Industries, LP
Inspection Date
July 18, 2025
Product Type
Human Drugs
Office
Minneapolis District Office
Person
  • Elizabeth R. Bloom (Issuing Officer)
View Company Profile

ID · 849d1867-6ecd-4688-b9e1-9c1ad5dc8620

Inspection Facts

Inspection number
1269620
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued, view the record

FDA Citations

8
  1. 21 CFR 211.122(d)Labels and labeling stored separately
  2. 21 CFR 211.125(a)Strict control not exercised over labeling issued
  3. 21 CFR 211.192Investigations of discrepancies, failures
  4. 21 CFR 211.194(a)(1)Sample identification and other information
  5. 21 CFR 211.22(d)Procedures not in writing, fully followed
  6. 21 CFR 211.42(c)(2)Rejected Material Area
  7. 21 CFR 211.68(b)Computer control of master formula records
  8. 21 CFR 211.84(d)(1)Identity Testing of Each Component

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Medline Industries, LP

1
DateClassificationOfficeProject area
May 25, 2018VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Medline Industries, LP
  • FDA Inspection 1054500 - 2018-05-25

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