VitaCare Labs Inc.
Form 483 issued May 16, 2025
- Inspection
- May 12 – May 16, 2025
- Investigator
- Hung H. Do
- Observations
- 6
- Pages
- 11
- FEI number
- 3008920776
In short: On May 16, 2025, FDA issued a Form 483 with 6 observations to VitaCare Labs Inc. (FEI 3008920776) after an inspection that ran May 12 – May 16, 2025. The investigator was Hung H. Do. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and…
- 03
Batch production and control records do not include complete information relating to the production and…
- 04
The written stability testing…
This inspection in context
Hung H. Do
11 documents · 2021–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmVitaCare Labs Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at VitaCare Labs Inc.?
FDA listed 6 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected VitaCare Labs Inc.?
Hung H. Do is named on this Form 483, for the inspection of May 12 – May 16, 2025. Each investigator has a profile showing what they cite most.
When was VitaCare Labs Inc. inspected by FDA?
The inspection ran May 12 – May 16, 2025, and the Form 483 is dated May 16, 2025.
How do I get the full Form 483 for VitaCare Labs Inc.?
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.