Technichem Corp.
Form 483 issued March 18, 2020 · ANAHEIM, California
- Inspection
- Mar 12 – Mar 18, 2020
- Investigator
- Rumany C. Penn
- Observations
- 8
- Pages
- 6
- FEI number
- 3012112742
In short: On March 18, 2020, FDA issued a Form 483 with 8 observations to Technichem Corp. in ANAHEIM, California (FEI 3012112742) after an inspection that ran Mar 12 – Mar 18, 2020. The investigator was Rumany C. Penn. Most observations concern quality system and production.
At a glance
Quality system and production account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Equipment for adequate control over micro-organisms, dust, humidity and temperature is not provided when appropriate for…
- 02
Each lot of components, drug product containers and closures is not withheld from use until the…
- 03
The written stability testing program…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Rumany C. Penn
21 documents · 2016–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmTechnichem Corp. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.46(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Technichem Corp.?
FDA listed 8 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Technichem Corp.?
Rumany C. Penn is named on this Form 483, for the inspection of Mar 12 – Mar 18, 2020. Each investigator has a profile showing what they cite most.
When was Technichem Corp. inspected by FDA?
The inspection ran Mar 12 – Mar 18, 2020, and the Form 483 is dated March 18, 2020.
How do I get the full Form 483 for Technichem 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.