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FDA Inspection
•X-Cel Specialty Contacts•June 2, 2011

X-Cel Specialty Contacts – FDA Inspection, Jun 2, 2011

Record Details

This FDA Inspection record concerns X-Cel Specialty Contacts, with an inspection on June 2, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company
X-Cel Specialty Contacts
Inspection Date
June 2, 2011
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · dc54130f-0083-48aa-a912-16ed4ba48c2b

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
730345
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

4
  1. 21 CFR 820.198(a)Complaints
  2. 21 CFR 820.198(d)Evaluation, timeliness, identification
  3. 21 CFR 820.90(a)Nonconforming product control
  4. 21 CFR 803.17(a)(1)Lack of System for Event Evaluations

Full citation text and observation details available on the Dashboard.

Other FDA inspections of X-Cel Specialty Contacts

4
DateClassificationOfficeProject area
April 17, 2026Not classifiedAtlanta District Office
August 25, 2023NAICenter for Devices and Radiological HealthCompliance: Devices
March 1, 2017NAICenter for Devices and Radiological HealthCompliance: Devices
May 15, 2013NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for X-Cel Specialty Contacts
  • FDA Inspection 1319134 - 2026-04-17
  • FDA Inspection 1217610 - 2023-08-25
  • FDA Inspection 1004816 - 2017-03-01
  • FDA Inspection 832336 - 2013-05-15

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