Fragrance Manufacturing, Inc.
Form 483 issued September 14, 2022 · Allentown, Pennsylvania
- Investigator
- Michele Gottshall
- Observations
- 3
- Pages
- 3
- FEI number
- 3004479507
In short: On September 14, 2022, FDA issued a Form 483 with 3 observations to Fragrance Manufacturing, Inc. in Allentown, Pennsylvania (FEI 3004479507). The investigator was Michele Gottshall. Most observations concern facilities & equipment and production.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 03
Observation 3: scanned text, readable in the full document.
This inspection in context
Michele Gottshall
12 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmFragrance Manufacturing, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fragrance Manufacturing, Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Fragrance Manufacturing, Inc.?
Michele Gottshall is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Fragrance Manufacturing, Inc. inspected by FDA?
This Form 483 is dated September 14, 2022.
How do I get the full Form 483 for Fragrance 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.