Seereverse Karen A. Spencer

FDA investigator

Appears on 1 document from 2022, mostly at sites in New Jersey. Most often cites general requirements (21 CFR 211.160).

1
Documents on file
16.0
Observations per 483
2022
First seen
2022
Most recent

What they cite most

From 16 observations
  • 21 CFR 211.160
    General requirements
    2
  • 21 CFR 211.194
    Laboratory records
    2
  • 21 CFR 211.67
    Equipment cleaning and maintenance
    2
  • 21 CFR 111.105
    What must quality control personnel do?
    1
  • 21 CFR 111.113
    What quality control operations are required for a material review and disposition decision?
    1
  • 21 CFR 111.123
    What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations?
    1

Activity by year

2022: 1

Where

New Jersey 1

Is Seereverse Karen A. Spencer coming to your site?

Our team writes custom reports before an inspection: what this investigator cites most, how they write it up, and how your site's history compares, in one brief you can circulate.

Ask about any investigator in Claude or ChatGPT with the AI connector.

Inspection history

1 document, newest first
FirmOpen
483 Aspire Pharmaceuticals Inc.Feb 3, 2022 · Somerset, New Jersey

About this profile

What does Seereverse Karen A. Spencer inspect?

Seereverse Karen A. Spencer appears on 1 document on file covering 1 site, mostly in New Jersey.

What do they cite most often?

21 CFR 211.160 (general requirements), followed by 21 CFR 211.194 and 21 CFR 211.67.

Can I read the observations?

Each document page previews the opening words of every observation. The full documents are available to buy, one at a time or together.

How current is this profile?

The most recent document on file for Seereverse Karen A. Spencer is dated Feb 3, 2022.