Calmo Manufacturing Inc.
Form 483 issued August 23, 2019 · Huntington Beach, California
- Inspection
- Aug 19 – Aug 23, 2019
- Investigator
- Darren S. Brown
- Observations
- 4
- Pages
- 3
- FEI number
- 3007621443
In short: On August 23, 2019, FDA issued a Form 483 with 4 observations to Calmo Manufacturing Inc. in Huntington Beach, California (FEI 3007621443) after an inspection that ran Aug 19 – Aug 23, 2019. The investigator was Darren S. Brown. Most observations concern quality system and facilities & equipment.
At a glance
Observations span 3 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…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
The establishment of laboratory control mechanisms including any changes thereto, are not reviewed and approved by…
- 0421 CFR 11
Electronic records are used, but they do not meet retention requirements to ensure that they are…
This inspection in context
Darren S. Brown
27 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmCalmo Manufacturing Inc. 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 Calmo Manufacturing Inc.?
FDA listed 4 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Calmo Manufacturing Inc.?
Darren S. Brown is named on this Form 483, for the inspection of Aug 19 – Aug 23, 2019. Each investigator has a profile showing what they cite most.
When was Calmo Manufacturing Inc. inspected by FDA?
The inspection ran Aug 19 – Aug 23, 2019, and the Form 483 is dated August 23, 2019.
How do I get the full Form 483 for Calmo Manufacturing 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.