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Penn Highlands Elk, Saint Marys, PA – FDA Inspections

Inspection records and compliance data for Penn Highlands Elk in Saint Marys, PA. 9 FDA inspections on record, last inspected July 01, 2026.

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Company Profile

This profile covers Penn Highlands Elk based in Saint Marys, PA, United States.

FDA Inspection History

FDA inspections
9
OAI
0
VAI
0
NAI
0
Unclassified
9
Form 483s
0
Warning letters
0

First inspected May 19, 2017. Last inspected July 1, 2026.

FDA inspections (9)

DateResultFDA center(s)Insp. #
July 1, 2026Not classifiedMedical Devices & Rad Health1326022
May 22, 2025Not classifiedMedical Devices & Rad Health1286658
June 20, 2024Not classifiedMedical Devices & Rad Health1242725
June 2, 2023Not classifiedMedical Devices & Rad Health1207976
May 24, 2019Not classifiedMedical Devices & Rad Health1091728
May 24, 2018Not classifiedMedical Devices & Rad Health1054127
May 19, 2017Not classifiedMedical Devices & Rad Health1011912
May 19, 2017Not classifiedMedical Devices & Rad Health1011911
May 19, 2017Not classifiedMedical Devices & Rad Health1011822
FDA documents

No Form 483s, Warning Letters or EIRs on record.

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Abington Memorial Hospital
Diagnostic Medical Associates/UPMC
Tristan Associates-Middleburg Diagnostic Center
Hahnemann Univ. Hospital Mammography Services
St. Luke's University Hospital Women's Imaging Center
Company Information

Name

Penn Highlands Elk

FEI Number

1000522575

Address

763 Johnsonburg Rd, Saint Marys, PA 15857-3417, United States

Country

United States

ID: 76b379fb-8eb1-4f84-abb4-e1d166735850

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