Regenesis Pharmaceutica l I nc
Form 483 issued June 18, 2019 · Santa Ana, California
- Inspection
- Jun 11 – Jun 18, 2019
- Investigator
- Alan L. Truong
- Observations
- 12
- Pages
- 6
- FEI number
- 3015180086
In short: On June 18, 2019, FDA issued a Form 483 with 12 observations to Regenesis Pharmaceutica l I nc in Santa Ana, California (FEI 3015180086) after an inspection that ran Jun 11 – Jun 18, 2019. The investigator was Alan L. Truong. Most observations concern quality system and laboratory controls.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 0221 CFR 211.25(a)21 CFR 211
Employees are not given training in…
- 03
Procedures describing the handling of all written and oral complaints regarding a drug product are…
- 04
The identity of each component of a drug product is not verified by conducting at least…
This inspection in context
Alan L. Truong
16 documents · 2019–2025
Cites 211.188 (batch production and control records) more than any other section. Most of their documents are for sites in California.
The firmRegenesis Pharmaceutica l I nc history
The site's inspection history, in date order.
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 Regenesis Pharmaceutica l I nc?
FDA listed 12 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 Regenesis Pharmaceutica l I nc?
Alan L. Truong is named on this Form 483, for the inspection of Jun 11 – Jun 18, 2019. Each investigator has a profile showing what they cite most.
When was Regenesis Pharmaceutica l I nc inspected by FDA?
The inspection ran Jun 11 – Jun 18, 2019, and the Form 483 is dated June 18, 2019.
How do I get the full Form 483 for Regenesis Pharmaceutica l I nc?
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.