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FDA Inspection
•Allen Milling Technologies•June 25, 2026

Allen Milling Technologies – FDA Inspection, Jun 25, 2026

Record Details

This FDA Inspection record concerns Allen Milling Technologies, with an inspection on June 25, 2026, issued by the Los Angeles District Office, covering medical devices & rad health.

Company
Allen Milling Technologies
Inspection Date
June 25, 2026
Product Type
Medical Devices & Rad Health
Office
Los Angeles District Office
Person
  • Linda Galindo
View Company Profile

ID · 742bc507-2a6c-4e4f-b5bf-766f4014a476

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1323752
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices
Outcome
Form 483 issued, view the record

FDA Citations

7
  1. ISO 13485:2016 Clause 4.2.4Lack of document control
  2. ISO 13485:2016 Clause 5.1Lack of evidence for top management's commitment to QMS
  3. ISO 13485:2016 Clause 7.1Processes needed for product realization not planned and developed
  4. ISO 13485:2016 Clause 7.4.1Procedures for purchasing process not documented
  5. ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated
  6. ISO 13485:2016 Clause 8.3.1Nonconforming product not adequately evaluated
  7. ISO 13485:2016 Clause 8.5.2Corrective action not taken

Full citation text and observation details available on the Dashboard.

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