FDA Inspection
BioMed Laboratories, LLC.BioMed Laboratories, LLC. – FDA Inspection, Oct 31, 2025
Record Details
This FDA Inspection record concerns BioMed Laboratories, LLC., with an inspection on October 31, 2025, issued by the Dallas District Office, covering human drugs.
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ID · 78866863-96be-4496-9196-bcaa3cc5a42e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1291300
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.101(d)Verification of component addition
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.84(d)(2)Establish reliability of supplier's C of A
Full citation text and observation details available on the Dashboard.
Other FDA inspections of BioMed Laboratories, LLC.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| December 19, 2025 | VAI | Dallas District Office | Compliance: Medical Devices |
| 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 1296004 - 2025-12-19
- 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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