Rechon Life Science AB
FDA inspection history in Limhamn, Sweden, 2023 to 2025
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2023: one Form 483; 2024: one Form 483; 2025: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2023–25Two Form 483s and one warning letter, at Limhamn, Sweden.
- 2024The longest 483 on file: 6 observations over 8 pages at Limhamn, Sweden.
Cited most
Across all Rechon Life Science AB observations on file
- 21 CFR 211.42Design and construction features4
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.192Production record review2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.58Maintenance1
The complete Rechon Life Science AB 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
Limhamn, Sweden
Two Form 483s and one warning letter · 2023 to 2025 · 10 observations
Latest: Warning letter, Apr 30, 2025 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-04-30 | Warning letter Warning letter | Limhamn, Sweden | — | $99 |
| 2024-09-06 | 483 Form 483 | Limhamn, Sweden | 6 | $99 |
| 2023-03-17 | 483 Form 483 | Limhamn, Sweden | 4 | $99 |
FEI number 3002806978 · most recent document Apr 30, 2025
About Rechon Life Science AB
How many FDA Form 483s has Rechon Life Science AB received?
FDA Intel has 2 Form 483s on file for Rechon Life Science AB; the most recent is dated Sep 6, 2024.
When was Rechon Life Science AB last inspected by FDA?
The most recent FDA inspection document on file for Rechon Life Science AB is a Form 483 dated Sep 6, 2024, for the site in Limhamn, Sweden.
What did FDA cite at Rechon Life Science AB?
The regulations cited most in the observations on file for Rechon Life Science AB are 21 CFR 211.42 (Design and construction features), 4 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.192 (Production record review), 2 times.
Has Rechon Life Science AB received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Rechon Life Science AB; the most recent is dated Apr 30, 2025.