Profounda Inc.
FDA inspection history in Orlando, Florida, 2022 to 2023
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2022: one Form 483; 2023: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–23One Form 483 and one warning letter, at Orlando, Florida.
Cited most
Across all Profounda observations on file
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.192Production record review1
- 21 CFR 211.198(b)(2)Complaint files1
The complete Profounda file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Orlando, Florida
One warning letter and one Form 483 · 2022 to 2023 · 6 observations
Latest: Warning letter, Feb 1, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-02-01 | Warning letter Warning letter | Orlando, Florida | — | $99 |
| 2022-08-09 | 483 Form 483 | Orlando, Florida | 6 | $99 |
Investigators on these documents
FEI number 3011873350 · most recent document Feb 1, 2023
About Profounda Inc.
How many FDA Form 483s has Profounda Inc. received?
FDA Intel has 1 Form 483 on file for Profounda Inc.; the most recent is dated Aug 9, 2022.
When was Profounda Inc. last inspected by FDA?
The most recent FDA inspection document on file for Profounda Inc. is a Form 483 dated Aug 9, 2022, for the site in Orlando, Florida.
What did FDA cite at Profounda Inc.?
The regulations cited most in the observations on file for Profounda Inc. are 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.160(b) (General requirements), 1 time; 21 CFR 211.166(a) (Stability testing), 1 time.
Has Profounda Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Profounda Inc.; the most recent is dated Feb 1, 2023.