Pace Analytical Services
Form 483 issued May 23, 2024 · Williamsport, Pennsylvania
- Inspection
- May 21 – May 23, 2024
- Investigators
- Evan Tong· Karen A. Briggs
- Observations
- 4
- Pages
- 4
- FEI number
- 3012268760
In short: On May 23, 2024, FDA issued a Form 483 with 4 observations to Pace Analytical Services in Williamsport, Pennsylvania (FEI 3012268760) after an inspection that ran May 21 – May 23, 2024. The investigators were Evan Tong and Karen A. Briggs. Most observations concern materials and facilities & equipment.
At a glance
Observations span 4 systems, led by materials.
What FDA observed
Preview: the opening words of each observation- 01
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
- 02
There is a lack of written procedures assigning responsibility, providing cleaning schedules and describing in sufficient…
- 03
The establishment of laboratory control i nechanisms including any changes thereto, are not drafted by the…
- 04
GMP training is not conducted on a continuing basis to assure that employees remain familiar with…
This inspection in context
Evan Tong
6 documents · 2023–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmPace Analytical Services history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84(d)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pace Analytical Services?
FDA listed 4 observations on this Form 483, mostly about materials, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Pace Analytical Services?
Evan Tong and Karen A. Briggs are named on this Form 483, for the inspection of May 21 – May 23, 2024. Each investigator has a profile showing what they cite most.
When was Pace Analytical Services inspected by FDA?
The inspection ran May 21 – May 23, 2024, and the Form 483 is dated May 23, 2024.
How do I get the full Form 483 for Pace Analytical Services?
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.