K Patel Phyto Extractions Private Limited
Form 483 issued April 28, 2023 · Valsad, India
- Investigator
- Rachael O. Oyewole
- Observations
- 1
- Pages
- 1
- FEI number
- 3005651681
In short: On April 28, 2023, FDA issued a Form 483 with 1 observation to K Patel Phyto Extractions Private Limited in Valsad, Gujarat (FEI 3005651681). The investigator was Rachael O. Oyewole. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies do not always include…
This inspection in context
Rachael O. Oyewole
10 documents · 2020–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmK Patel Phyto Extractions Private Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at K Patel Phyto Extractions Private Limited?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected K Patel Phyto Extractions Private Limited?
Rachael O. Oyewole is named on this Form 483. Each investigator has a profile showing what they cite most.
When was K Patel Phyto Extractions Private Limited inspected by FDA?
This Form 483 is dated April 28, 2023.
How do I get the full Form 483 for K Patel Phyto Extractions Private Limited?
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.