PTI Royston, LLC
Form 483 issued January 16, 2026 · Royston, Georgia
- Inspection
- Jan 8 – Jan 16, 2026
- Investigators
- Steven A. Brettler· Veronica Fuentes
- Observations
- 9
- Pages
- 13
- FEI number
- 3005372036
In short: On January 16, 2026, FDA issued a Form 483 with 9 observations to PTI Royston, LLC in Royston, Georgia (FEI 3005372036) after an inspection that ran Jan 8 – Jan 16, 2026. The investigators were Steven A. Brettler and Veronica Fuentes. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
Quality system and laboratory controls account for 6 of 9 observations.
Most cited: 21 CFR 211.100(a) (2×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
The establishment of specifications, sampling plans, test procedures and laboratory control mechanisms including any changes thereto…
- 02
All records of control associated with a batch of drug product were not maintained at least…
- 03
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 04
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
This inspection in context
Steven A. Brettler
15 documents · 2021–2026
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Florida.
The firmPTI Royston, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PTI Royston, LLC?
FDA listed 9 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected PTI Royston, LLC?
Steven A. Brettler and Veronica Fuentes are named on this Form 483, for the inspection of Jan 8 – Jan 16, 2026. Each investigator has a profile showing what they cite most.
When was PTI Royston, LLC inspected by FDA?
The inspection ran Jan 8 – Jan 16, 2026, and the Form 483 is dated January 16, 2026.
How do I get the full Form 483 for PTI Royston, 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.