Tower Laboratories Ltd
FDA inspection history in Montague, Michigan, 2019 to 2025
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2019: one Form 483; 2021: one Form 483; 2025: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–21Two Form 483s, at Montague, Michigan.
- 2021The longest 483 on file: 4 observations over 6 pages at Montague, Michigan.
- 2025One warning letter, at Montague, Michigan.
Cited most
Across all Tower Laboratories observations on file
- 21 CFR 111.320(a)What requirements apply to laboratory methods for testing and examination?1
- 21 CFR 211.100(b)Written procedures; deviations1
- 21 CFR 211.110(b)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.192Production record review1
The complete Tower 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
Montague, Michigan
Two Form 483s and one warning letter · 2019 to 2025 · 5 observations
Latest: Warning letter, Dec 23, 2025 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-12-23 | Warning letter Warning letter | Montague, Michigan | — | $99 |
| 2021-11-17 | 483 Form 483 | Montague, Michigan | 4 | $99 |
| 2019-05-02 | 483 Form 483 | Montague, Michigan | 1 | $99 |
Investigators on these documents
FEI number 1823985 · most recent document Dec 23, 2025
About Tower Laboratories Ltd
How many FDA Form 483s has Tower Laboratories Ltd received?
FDA Intel has 2 Form 483s on file for Tower Laboratories Ltd; the most recent is dated Nov 17, 2021.
When was Tower Laboratories Ltd last inspected by FDA?
The most recent FDA inspection document on file for Tower Laboratories Ltd is a Form 483 dated Nov 17, 2021, for the site in Montague, Michigan.
What did FDA cite at Tower Laboratories Ltd?
The regulations cited most in the observations on file for Tower Laboratories Ltd are 21 CFR 111.320(a) (What requirements apply to laboratory methods for testing and examination?), 1 time; 21 CFR 211.100(b) (Written procedures; deviations), 1 time; 21 CFR 211.110(b) (Sampling and testing of in-process materials and drug products), 1 time.
Has Tower Laboratories Ltd received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Tower Laboratories Ltd; the most recent is dated Dec 23, 2025.