SOFTAP INC
Form 483 issued December 11, 2023 · Livermore, California
- Inspection
- Dec 7 – Dec 11, 2023
- Investigator
- Gunneet Kaur
- Observations
- 7
- Pages
- 5
- FEI number
- 3013155761
In short: On December 11, 2023, FDA issued a Form 483 with 7 observations to SOFTAP INC in Livermore, California (FEI 3013155761) after an inspection that ran Dec 7 – Dec 11, 2023. The investigator was Gunneet Kaur. Most observations concern quality system and materials.
At a glance
Quality system and materials account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Written distribution procedures are…
- 03
Procedures describing the handling of written and oral complaints related to drug products are…
- 04
Reserve drug product samples are not representative of each lot or…
This inspection in context
Gunneet Kaur
9 documents · 2021–2024
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmSOFTAP 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 SOFTAP INC?
FDA listed 7 observations on this Form 483, mostly about quality system, materials and laboratory controls. The opening words of each observation are shown on this page.
Who inspected SOFTAP INC?
Gunneet Kaur is named on this Form 483, for the inspection of Dec 7 – Dec 11, 2023. Each investigator has a profile showing what they cite most.
When was SOFTAP INC inspected by FDA?
The inspection ran Dec 7 – Dec 11, 2023, and the Form 483 is dated December 11, 2023.
How do I get the full Form 483 for SOFTAP 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.