Prisha Cosmetics, Inc.
Form 483 issued November 22, 2024 · Chatsworth, California
- Inspection
- Nov 19 – Nov 22, 2024
- Investigators
- Aranjeet Singh· Pearl C. Ozuruigbo· Thuy T. Nguyen
- Observations
- 6
- Pages
- 8
- FEI number
- 3010364830
In short: On November 22, 2024, FDA issued a Form 483 with 6 observations to Prisha Cosmetics, Inc. in Chatsworth, California (FEI 3010364830) after an inspection that ran Nov 19 – Nov 22, 2024. The investigators were Aranjeet Singh, Pearl C. Ozuruigbo, Thuy T. Nguyen and Youkeun Kim. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
There is no written testing program designed to assess the stability…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
This inspection in context
Aranjeet Singh
3 documents · 2024–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmPrisha Cosmetics, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Prisha Cosmetics, Inc.?
FDA listed 6 observations on this Form 483, mostly about production, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Prisha Cosmetics, Inc.?
Aranjeet Singh, Pearl C. Ozuruigbo, Thuy T. Nguyen and Youkeun Kim are named on this Form 483, for the inspection of Nov 19 – Nov 22, 2024. Each investigator has a profile showing what they cite most.
When was Prisha Cosmetics, Inc. inspected by FDA?
The inspection ran Nov 19 – Nov 22, 2024, and the Form 483 is dated November 22, 2024.
How do I get the full Form 483 for Prisha Cosmetics, 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.