Unilever Covington
Form 483 issued December 11, 2009 · Covington, Tennessee
- Inspection
- Dec 3 – Dec 11, 2009
- Investigators
- Andrew F. Saunders· Cheryl G. Scott· David R. Heiar
- Observations
- 3
- Pages
- 1
- FEI number
- 3002147105
In short: On December 11, 2009, FDA issued a Form 483 with 3 observations to Unilever Covington in Covington, Tennessee (FEI 3002147105) after an inspection that ran Dec 3 – Dec 11, 2009. The investigators were Andrew F. Saunders, Cheryl G. Scott, David R. Heiar, Lindsay M. Hughes and Marcus L. Head. The most-cited regulation is 21 CFR 113.100 (processing and production records).
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 0121 CFR 113.100
Entries on aseptic system processing records were not made at the time the specific…
- 0221 CFR 113.89
Process deviations were not recorded in a separate file or log that details both the deviation…
- 03
Investigations of elevated (b) (4) kick out/reject rates and Spoilage Reports have not been adequately described…
This inspection in context
Andrew F. Saunders
3 documents · 2009–2015
Cites 110.10 (personnel) more than any other section. Most of their documents are for sites in Tennessee.
The firmUnilever Covington history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Unilever Covington?
FDA listed 3 observations on this Form 483. The most-cited regulation is 21 CFR 113.100 (processing and production records). The opening words of each observation are shown on this page.
Who inspected Unilever Covington?
Andrew F. Saunders, Cheryl G. Scott, David R. Heiar, Lindsay M. Hughes and Marcus L. Head are named on this Form 483, for the inspection of Dec 3 – Dec 11, 2009. Each investigator has a profile showing what they cite most.
When was Unilever Covington inspected by FDA?
The inspection ran Dec 3 – Dec 11, 2009, and the Form 483 is dated December 11, 2009.
How do I get the full Form 483 for Unilever Covington?
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.