Formulation Technology Incorporated
FDA inspection history in Oakdale, California, 2020 to 2025
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2020: one Form 483; 2023: one Form 483; 2024: one warning letter; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at Oakdale, California.
- 2023–25Two Form 483s and one warning letter, at Oakdale, California.
- 2025The longest 483 on file: 8 observations over 11 pages at Oakdale, California.
Cited most
Across all Formulation Technology Incorporated observations on file
- 21 CFR 211.22(d)Responsibilities of quality control unit2
- 21 CFR 211.68(b)Automatic, mechanical, and electronic equipment2
- 21 CFR 111.105(a)What must quality control personnel do?1
- 21 CFR 111.365(h)What precautions must you take to prevent contamination?1
- 21 CFR 117.35Sanitary operations1
The complete Formulation Technology Incorporated file.
All 4 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
Oakdale, California
Three Form 483s and one warning letter · 2020 to 2025 · 12 observations
Latest: Form 483, Mar 21, 2025 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-03-21 | 483 Form 483 | Oakdale, California | 8 | $99 |
| 2024-07-09 | Warning letter Warning letter | Oakdale, California | — | $99 |
| 2023-11-09 | 483 Form 483 | Oakdale, California | 2 | $99 |
| 2020-01-10 | 483 Form 483 | Oakdale, California | 2 | $99 |
Investigators on these documents
Ashley J. Allen Gaines (1)Breena L. Dambrogi (1)Duc-Minh H. Nguyen (1)Scott N. Lim (1)Tomanik'e C. Banks (1)Tomanik Le Banks (1)
FEI number 2937960 · most recent document Mar 21, 2025
About Formulation Technology Incorporated
How many FDA Form 483s has Formulation Technology Incorporated received?
FDA Intel has 3 Form 483s on file for Formulation Technology Incorporated; the most recent is dated Mar 21, 2025.
When was Formulation Technology Incorporated last inspected by FDA?
The most recent FDA inspection document on file for Formulation Technology Incorporated is a Form 483 dated Mar 21, 2025, for the site in Oakdale, California.
What did FDA cite at Formulation Technology Incorporated?
The regulations cited most in the observations on file for Formulation Technology Incorporated are 21 CFR 211.22(d) (Responsibilities of quality control unit), 2 times; 21 CFR 211.68(b) (Automatic, mechanical, and electronic equipment), 2 times; 21 CFR 111.105(a) (What must quality control personnel do?), 1 time.
Has Formulation Technology Incorporated received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Formulation Technology Incorporated; the most recent is dated Jul 9, 2024.