Playtex Manufacturing Inc.
Form 483 issued April 7, 2025 · Sidney, Ohio
- Inspection
- Mar 31 – Apr 7, 2025
- Investigator
- Ucheabuchi C. Chudi-Nwankwor
- Observations
- 6
- Pages
- 6
- FEI number
- 3000717960
In short: On April 7, 2025, FDA issued a Form 483 with 6 observations to Playtex Manufacturing Inc. in Sidney, Ohio (FEI 3000717960) after an inspection that ran Mar 31 – Apr 7, 2025. The investigator was Ucheabuchi C. Chudi-Nwankwor. 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
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standardsand test procedures…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Ucheabuchi C. Chudi-Nwankwor
22 documents · 2016–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Ohio.
The firmPlaytex Manufacturing Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Playtex Manufacturing Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Playtex Manufacturing Inc.?
Ucheabuchi C. Chudi-Nwankwor is named on this Form 483, for the inspection of Mar 31 – Apr 7, 2025. Each investigator has a profile showing what they cite most.
When was Playtex Manufacturing Inc. inspected by FDA?
The inspection ran Mar 31 – Apr 7, 2025, and the Form 483 is dated April 7, 2025.
How do I get the full Form 483 for Playtex Manufacturing 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.