FDA Inspection
BioMed Laboratories, LLC.BioMed Laboratories, LLC. – FDA Inspection, Dec 19, 2025
Record Details
This FDA Inspection record concerns BioMed Laboratories, LLC., with an inspection on December 19, 2025, issued by the Dallas District Office, covering medical devices & rad health.
- Company
- BioMed Laboratories, LLC.
- Inspection Date
- December 19, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 8226804a-6482-4954-8ee5-b1c234fcd5db
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1296004
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.30(h)Incorrect translation to production specifications
Full citation text and observation details available on the Dashboard.
Other FDA inspections of BioMed Laboratories, LLC.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| October 31, 2025 | OAI | Dallas District Office | Drug Quality Assurance |
| October 13, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 11, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 27, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 1, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for BioMed Laboratories, LLC.
- FDA Inspection 1291300 - 2025-10-31
- FDA Inspection 1155482 - 2021-10-13
- FDA Inspection 1068501 - 2018-10-11
- FDA Inspection 1069006 - 2018-07-27
- FDA Inspection 1028289 - 2017-09-01
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