Form 483 · FEI 3009713694
Form 483 issued June 23, 2023 · Toledo, Spain
- Inspection
- Jun 15 – Jun 23, 2023
- Investigators
- Pratik S. Upadhyay· Xiaokuang Lai
- Observations
- 7
- Pages
- 17
- FEI number
- 3009713694
In short: On June 23, 2023, FDA issued a Form 483 with 7 observations to an FDA-inspected site in Toledo, Spain (FEI 3009713694) after an inspection that ran Jun 15 – Jun 23, 2023. The investigators were Pratik S. Upadhyay and Xiaokuang Lai. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 6 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Written records of investigation of a drug complaint do not include the…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
This inspection in context
Pratik S. Upadhyay
48 documents · 2011–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmSite history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 7 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Pratik S. Upadhyay and Xiaokuang Lai are named on this Form 483, for the inspection of Jun 15 – Jun 23, 2023. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jun 15 – Jun 23, 2023, and the Form 483 is dated June 23, 2023.
How do I get the full Form 483 for an FDA-inspected site?
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.