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FDA Inspection
•Ultra Seal Corporation•August 3, 2010

Ultra Seal Corporation – FDA Inspection, Aug 3, 2010

Record Details

This FDA Inspection record concerns Ultra Seal Corporation, with an inspection on August 3, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Ultra Seal Corporation
Inspection Date
August 3, 2010
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · cf8ce301-68f0-48c5-bdad-cd678f25ad8d

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
677224
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

4
  1. 21 CFR 211.80(d)Status of Each Lot Identified
  2. 21 CFR 211.130(e)Packaging line inspection after use
  3. 21 CFR 211.130Procedures are written, and followed
  4. 21 CFR 211.67(c)Cleaning/maintenance records not kept

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Ultra Seal Corporation

12
DateClassificationOfficeProject area
September 3, 2026VAINew York District OfficeDrug Quality Assurance
March 4, 2025NAICenter for Tobacco ProductsTobacco Post-Market Activities
May 2, 2024NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
February 5, 2024NAICenter for Tobacco ProductsTobacco Post-Market Activities
September 20, 2023VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 12 other inspections on the company page
Other documents for Ultra Seal Corporation
  • FDA Inspection 1338618 - 2026-09-03
  • FDA Inspection 1263334 - 2025-03-04
  • FDA Inspection 1229281 - 2024-05-02
  • FDA Inspection 1228761 - 2024-02-05
  • FDA Inspection 1218129 - 2023-09-20

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