Deserving Health International Corp.
Form 483 issued July 14, 2017 · Richmond, Canada
- Inspection
- Jul 10 – Jul 14, 2017
- Investigator
- Erika V. Butler
- Observations
- 20
- Pages
- 11
- FEI number
- 3012271380
In short: On July 14, 2017, FDA issued a Form 483 with 20 observations to Deserving Health International Corp. in Richmond, British Columbia (FEI 3012271380) after an inspection that ran Jul 10 – Jul 14, 2017. The investigator was Erika V. Butler. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
The operations relating to the manufacture, processing and packing of penicillin are not performed in facilities…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Erika V. Butler
23 documents · 2007–2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
The firmDeserving Health International Corp. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Deserving Health International Corp.?
FDA listed 20 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Deserving Health International Corp.?
Erika V. Butler is named on this Form 483, for the inspection of Jul 10 – Jul 14, 2017. Each investigator has a profile showing what they cite most.
When was Deserving Health International Corp. inspected by FDA?
The inspection ran Jul 10 – Jul 14, 2017, and the Form 483 is dated July 14, 2017.
How do I get the full Form 483 for Deserving Health International Corp.?
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.