The Procter & Gamble Manufacturing Company
Form 483 issued March 10, 2017 · Browns Summit, North Carolina
- Inspection
- Mar 6 – Mar 10, 2017
- Investigators
- Daveta L. Bailey· Kara D. Dobbin
- Observations
- 1
- Pages
- 1
- FEI number
- 1033800
In short: On March 10, 2017, FDA issued a Form 483 with 1 observation to The Procter & Gamble Manufacturing Company in Browns Summit, North Carolina (FEI 1033800) after an inspection that ran Mar 6 – Mar 10, 2017. The investigators were Daveta L. Bailey and Kara D. Dobbin. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194(a)(8) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory records do not include the initials or signature of a second person showing that the…
This inspection in context
Daveta L. Bailey
2 documents · 2017–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Illinois.
The firmThe Procter & Gamble Manufacturing Company history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194(a)(8)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at The Procter & Gamble Manufacturing Company?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected The Procter & Gamble Manufacturing Company?
Daveta L. Bailey and Kara D. Dobbin are named on this Form 483, for the inspection of Mar 6 – Mar 10, 2017. Each investigator has a profile showing what they cite most.
When was The Procter & Gamble Manufacturing Company inspected by FDA?
The inspection ran Mar 6 – Mar 10, 2017, and the Form 483 is dated March 10, 2017.
How do I get the full Form 483 for The Procter & Gamble Manufacturing Company?
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.