August Bioservices, LLC
Form 483 issued April 18, 2025 · Nashville, Tennessee
- Investigators
- Camerson E. Moore· Inga M. Warr
- Observations
- 3
- Pages
- 22
- FEI number
- 3017298490
In short: On April 18, 2025, FDA issued a Form 483 with 3 observations to August Bioservices, LLC in Nashville, Tennessee (FEI 3017298490). The investigators were Camerson E. Moore and Inga M. Warr. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
3 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×) · 211.42 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Production areas have difficult to clean or contain porous, particle generating, or visibly…
- 02
The sinks are present directly adjacent to…
- 03
Beta-lactam drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or…
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmAugust Bioservices, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at August Bioservices, LLC?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected August Bioservices, LLC?
Camerson E. Moore and Inga M. Warr are named on this Form 483. Each investigator has a profile showing what they cite most.
When was August Bioservices, LLC inspected by FDA?
This Form 483 is dated April 18, 2025.
How do I get the full Form 483 for August Bioservices, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.