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FDA Inspection
•Walter's Pharmacy, Inc.•March 1, 2016

Walter's Pharmacy, Inc. – FDA Inspection, Mar 1, 2016

Record Details

This FDA Inspection record concerns Walter's Pharmacy, Inc., with an inspection on March 1, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Walter's Pharmacy, Inc.
Inspection Date
March 1, 2016
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 1470afc8-005c-4356-a64c-6371bf2debce

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
960809
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

5
  1. 21 CFR 211.84(d)(1)Component identity verification
  2. 21 CFR 211.113(b)Procedures for sterile drug products
  3. 21 CFR 211.28(a)Protective Apparel Not Worn
  4. 21 CFR 211.42(c)(10)Aseptic Processing Area
  5. 21 CFR 211.166(a)Lack of written stability program

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Walter's Pharmacy, Inc.

1
DateClassificationOfficeProject area
October 25, 2017Not classifiedPhiladelphia District Office
Other documents for Walter's Pharmacy, Inc.
  • FDA Inspection 1031881 - 2017-10-25

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