Dextrum Laboratories Inc
FDA inspection history in Miami, Florida, 2022 to 2024
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2022: one Form 483; 2023: one warning letter; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–24Two Form 483s and one warning letter, at Miami, Florida.
- 2022The longest 483 on file: 10 observations over 6 pages at Miami, Florida.
Cited most
Across all Dextrum Laboratories observations on file
- 21 CFR 211.113(a)Control of microbiological contamination2
- 21 CFR 211.166(a)Stability testing2
- 21 CFR 211.22(d)Responsibilities of quality control unit2
- 21 CFR 211.63Equipment design, size, and location2
- 21 CFR 211.100(b)Written procedures; deviations1
The complete Dextrum Laboratories file.
All 3 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
Miami, Florida
Two Form 483s and one warning letter · 2022 to 2024 · 16 observations
Latest: Form 483, Aug 29, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-08-29 | 483 Form 483 | Miami, Florida | 6 | $99 |
| 2023-12-07 | Warning letter Warning letter | Miami, Florida | — | $99 |
| 2022-12-16 | 483 Form 483 | Miami, Florida | 10 | $99 |
Investigators on these documents
Harshal J. Desai (1)J'maica J. Hunter (1)Jennifer Lalama (1)
FEI number 3003092372 · most recent document Aug 29, 2024
About Dextrum Laboratories Inc
How many FDA Form 483s has Dextrum Laboratories Inc received?
FDA Intel has 2 Form 483s on file for Dextrum Laboratories Inc; the most recent is dated Aug 29, 2024.
When was Dextrum Laboratories Inc last inspected by FDA?
The most recent FDA inspection document on file for Dextrum Laboratories Inc is a Form 483 dated Aug 29, 2024, for the site in Miami, Florida.
What did FDA cite at Dextrum Laboratories Inc?
The regulations cited most in the observations on file for Dextrum Laboratories Inc are 21 CFR 211.113(a) (Control of microbiological contamination), 2 times; 21 CFR 211.166(a) (Stability testing), 2 times; 21 CFR 211.22(d) (Responsibilities of quality control unit), 2 times.
Has Dextrum Laboratories Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Dextrum Laboratories Inc; the most recent is dated Dec 7, 2023.