Acuity Specialty Products, Inc dba AFCO US
Form 483 issued March 14, 2025 · Chambersburg, Pennsylvania
- Inspection
- Mar 10 – Mar 14, 2025
- Investigators
- Elena M. Thomas· Evan Tong· Ruben C. Quintana
- Observations
- 9
- Pages
- 10
- FEI number
- 3006317477
In short: On March 14, 2025, FDA issued a Form 483 with 9 observations to Acuity Specialty Products, Inc dba AFCO US in Chambersburg, Pennsylvania (FEI 3006317477) after an inspection that ran Mar 10 – Mar 14, 2025. The investigators were Elena M. Thomas, Evan Tong and Ruben C. Quintana. Most observations concern quality system and laboratory controls.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Specific identification tests are not conducted on components that have been accepted based on the…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures…
- 03
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
- 04
Routine calibration, inspection and checking of mechanical equipment is not performed according to a written program…
This inspection in context
Elena M. Thomas
2 documents · 2024–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmAcuity Specialty Products, Inc dba AFCO US 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 Acuity Specialty Products, Inc dba AFCO US?
FDA listed 9 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Acuity Specialty Products, Inc dba AFCO US?
Elena M. Thomas, Evan Tong and Ruben C. Quintana are named on this Form 483, for the inspection of Mar 10 – Mar 14, 2025. Each investigator has a profile showing what they cite most.
When was Acuity Specialty Products, Inc dba AFCO US inspected by FDA?
The inspection ran Mar 10 – Mar 14, 2025, and the Form 483 is dated March 14, 2025.
How do I get the full Form 483 for Acuity Specialty Products, Inc dba AFCO US?
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.