FDA Inspection
Superior Labs IncSuperior Labs Inc – FDA Inspection, Aug 11, 2026
Record Details
This FDA Inspection record concerns Superior Labs Inc, with an inspection on August 11, 2026, issued by the Atlanta District Office, covering medical devices & rad health.
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ID · a3ce55e7-994b-4e6b-8315-dfde8aa338bf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1330542
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.35(c)UDI was not recorded for each medical device or batch
- ISO 13485:2016 Clause 4.1.1QMS not documented and maintained adequately
- ISO 13485:2016 Clause 7.1Planning of product realization not consistent with other QMS processes
- ISO 13485:2016 Clause 7.3.2Design and development of product not planned and controlled
- ISO 13485:2016 Clause 7.4.3Records of purchased product verification not maintained
- ISO 13485:2016 Clause 7.5.1Production and service provision not adequate
- ISO 13485:2016 Clause 7.6Equipment calibration or verification not performed
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
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