FDA Inspection
Playtex Manufacturing IncPlaytex Manufacturing Inc – FDA Inspection, Nov 3, 2017
Record Details
This FDA Inspection record concerns Playtex Manufacturing Inc, with an inspection on November 3, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Angela E. Glenn (Issuing Officer)
- Saundrea A. Munroe (FDA Associated Person)
View Company Profile
ID · 081c54ac-ec53-4aaa-ad6d-7f0edaaa7ac3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1030617
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.65(a)Equipment construction - reactive surfaces
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.160(b)(1)Samples (various types) representative, identified properly
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(a)Written Procedures Not Followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Playtex Manufacturing Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 10, 2026 | Not classified | Florida District Office | Drug Quality Assurance |
| April 19, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 12, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 21, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Playtex Manufacturing Inc
- FDA Inspection 1314132 - 2026-07-10
- FDA Inspection 1203164 - 2023-04-19
- FDA Inspection 961732 - 2016-02-12
- FDA Inspection 605425 - 2009-08-21
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.