Playtex Manufacturing Inc
Form 483 issued April 19, 2023 · Ormond Beach, Florida
- Inspection
- Apr 13 – Apr 19, 2023
- Investigator
- Brittny C. Cargo
- Observations
- 4
- Pages
- 4
- FEI number
- 1027735
In short: On April 19, 2023, FDA issued a Form 483 with 4 observations to Playtex Manufacturing Inc in Ormond Beach, Florida (FEI 1027735) after an inspection that ran Apr 13 – Apr 19, 2023. The investigator was Brittny C. Cargo. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Input to and output from the computer and records or data are…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Written records of investigations into the failure of a batch or any of its components to…
- 04
Written procedures are not followed for the receipt…
This inspection in context
Brittny C. Cargo
14 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Louisiana.
The firmPlaytex Manufacturing Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Playtex Manufacturing Inc?
FDA listed 4 observations on this Form 483, mostly about quality system, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Playtex Manufacturing Inc?
Brittny C. Cargo is named on this Form 483, for the inspection of Apr 13 – Apr 19, 2023. Each investigator has a profile showing what they cite most.
When was Playtex Manufacturing Inc inspected by FDA?
The inspection ran Apr 13 – Apr 19, 2023, and the Form 483 is dated April 19, 2023.
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.