Formulation Technology Incorporated
Form 483 issued March 21, 2025 · Oakdale, California
- Inspection
- Mar 10 – Mar 21, 2025
- Observations
- 8
- Pages
- 11
- FEI number
- 2937960
In short: On March 21, 2025, FDA issued a Form 483 with 8 observations to Formulation Technology Incorporated in Oakdale, California (FEI 2937960) after an inspection that ran Mar 10 – Mar 21, 2025. Most observations concern quality system and dietary supplement CGMP.
At a glance
Quality system and dietary supplement cgmp account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 0121 CFR 111.365(h)
You did not perform mechanical manufacturing steps by effective means to protect the…
- 02
Your quality control personnel did not approve or reject processes, written procedures, controls, tests and deviations…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Written procedures are not followed for evaluations conducted at least annually to review records associated with…
This inspection in context
Questions about this 483
What did FDA find at Formulation Technology Incorporated?
FDA listed 8 observations on this Form 483, mostly about quality system, dietary supplement CGMP and facilities & equipment. The opening words of each observation are shown on this page.
When was Formulation Technology Incorporated inspected by FDA?
The inspection ran Mar 10 – Mar 21, 2025, and the Form 483 is dated March 21, 2025.
How do I get the full Form 483 for Formulation Technology Incorporated?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.