Straight Arrow Products, Inc.
Form 483 issued October 15, 2024 · Easton, Pennsylvania
- Inspection
- Oct 7 – Oct 15, 2024
- Investigators
- Anastasia M. Shields· Lu Chen
- Observations
- 6
- Pages
- 7
- FEI number
- 3014727651
In short: On October 15, 2024, FDA issued a Form 483 with 6 observations to Straight Arrow Products, Inc. in Easton, Pennsylvania (FEI 3014727651) after an inspection that ran Oct 7 – Oct 15, 2024. The investigators were Anastasia M. Shields and Lu Chen. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 03
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmStraight Arrow Products, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Straight Arrow Products, Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Straight Arrow Products, Inc.?
Anastasia M. Shields and Lu Chen are named on this Form 483, for the inspection of Oct 7 – Oct 15, 2024. Each investigator has a profile showing what they cite most.
When was Straight Arrow Products, Inc. inspected by FDA?
The inspection ran Oct 7 – Oct 15, 2024, and the Form 483 is dated October 15, 2024.
How do I get the full Form 483 for Straight Arrow Products, Inc.?
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.