Screening sterile OTC monograph products for microbial contamination
Ended Purchase Order Awarded Last action
- Contract number
- 75F40125P00197
- Awardee
-
Element Materials Technology Holding USA Inc. UEI MEQWYA9G5DX5
- Awarding agency
-
Food and Drug Administration
Department of Health and Human Services
- Obligated
- $0
Award facts
- Contract value
- $0.00 Current and potential, with all options
- Completion date 100% complete
- Current and potential, with all options
- Contracting staff
- NAICS code
- 541380 Testing Laboratories and Services
- PSC
- Q301 Reference Laboratory Testing
- Set-aside
- No set-aside
- Competition
- Competed under SAP · 2 offers Simplified Acquisition
- Pricing
- Firm Fixed Price
- Place of performance
- Concord, CA 94520, USA
- Legislative mandates
-
- Service Contract Inventory FAR subpart 4.17
Award details come from SAM.gov/FPDS.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Close Out | -$186,700 | |
| Terminate for Convenience | $0 | |
| Original award | $186,700 |
About this award
The Food and Drug Administration (FDA) awarded a $186.7K firm fixed-price purchase order to Element Materials Technology Holding USA Inc. on August 27, 2025, for screening sterile over-the-counter (OTC) monograph products for microbial contamination. The contract, with a performance location in Concord, California, is scheduled for completion by September 15, 2026, and carries no set-aside designation, indicating competitive procurement. Element Materials Technology, doing business as Element Materials Technology Melbourne, is a foreign-owned laboratory testing firm headquartered in Fairfield, Ohio, that specializes in pharmaceutical and medical product analysis services.
This award reflects the FDA's ongoing quality assurance mission to ensure drug safety and compliance within the OTC pharmaceutical market. The contract represents Element Materials Technology's continued engagement with the FDA on microbiological testing services; the company has secured multiple related contracts totaling approximately $567.7K for both sterile and non-sterile OTC monograph product screening through September 2026. These firm fixed-price purchase orders demonstrate the contractor's established technical capabilities in conducting detailed microbial contamination testing and surveillance activities that support the agency's regulatory oversight of pharmaceutical product safety.
Quick answers
Who was awarded contract 75F40125P00197?
75F40125P00197 was awarded to Element Materials Technology Holding USA Inc. by Food and Drug Administration (Department of Health and Human Services) on August 27, 2025.
How much is contract 75F40125P00197 worth?
The government has obligated $0 on 75F40125P00197.
Was contract 75F40125P00197 competed?
The extent of competition for 75F40125P00197 was competed under sap. The government received 2 offers.
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