PTI Royston, LLC
Form 483 issued February 6, 2020 · Royston, Georgia
- Inspection
- Feb 3 – Feb 6, 2020
- Investigator
- Susan O. Oladeji
- Observations
- 6
- Pages
- 4
- FEI number
- 3005372036
In short: On February 6, 2020, FDA issued a Form 483 with 6 observations to PTI Royston, LLC in Royston, Georgia (FEI 3005372036) after an inspection that ran Feb 3 – Feb 6, 2020. The investigator was Susan O. Oladeji. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Quality system and laboratory controls account for 6 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Written procedures are not established and followed for evaluations done at least annually and including provisions…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Susan O. Oladeji
15 documents · 2017–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Georgia.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PTI Royston, LLC?
FDA listed 6 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected PTI Royston, LLC?
Susan O. Oladeji is named on this Form 483, for the inspection of Feb 3 – Feb 6, 2020. Each investigator has a profile showing what they cite most.
When was PTI Royston, LLC inspected by FDA?
The inspection ran Feb 3 – Feb 6, 2020, and the Form 483 is dated February 6, 2020.
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.